MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	G56201
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
As reported, during an unknown procedure, the wire included in a micropuncture transitionless access set separated.Reportedly, the wire broke lengthwise and a thin thread of wire remained in the patient.The fragment was eventually removed safely.Additional information has been requested.
Additional Manufacturer Narrative
The patient weighed 900 grams (0.9kg).This was rounded to 1kg for section a4.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was received 05apr2023.The procedure was central venous catheter placement in the jugular vein.The yellow micropuncture needle was introduced into the premature neonate and the wire passed through the needle without difficulty.The wire unraveled upon removal but did not completely separate.Another introducer was then used to "have a wider space" to pull back and remove the wire.The procedure had to be re-started.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5 summary of event: as reported, during an unknown procedure, the wire included in a micropuncture transitionless access set separated.Reportedly, the wire broke lengthwise, and a thin thread of wire remained in the patient.The fragment was eventually removed safely.Additional information was received 05apr2023.The procedure was central venous catheter placement in the jugular vein.The yellow micropuncture needle was introduced into the premature neonate and the wire passed through the needle without difficulty.The wire unraveled upon removal but did not completely separate.Another introducer was then used to "have a wider space" to pull back and remove the wire.The procedure had to be re-started.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was received 16jun2023.The jugular access site was not tortuous or calcified.It is unknown if resistance was encountered upon insertion or removal of the device.The wire was not removed through the access needle.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and dimensional verification of the complaint device was also conducted.The complaint device was returned to cook for investigation, with part of the wire inside a small catheter (another unknown manufacturer).The wire was stretched and elongated; however, the weld ball was intact.The total length of the elongated wire was 56-centimeters.The proximal wire segment that was not unraveled measured 34.5-centimeters and the distal tip that was not unraveled measured approximately 4-centimeters.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number, and no non-conformances were noted on the final lot.Eight related non-conformances were noted on subassembly lots; however, all affected product was scrapped and there are 100% inspections in place to capture the non-conformance.There have been no complaints on any final lots associated with these subassembly lots.The product ifu cautions ¿when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position¿ do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt¿ withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Although relevant non-conformances were noted on a sub-assembly lots, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to design or manufacturing of the complaint device, contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was received 16jun2023.The jugular access site was not tortuous or calcified.It is unknown if resistance was encountered upon insertion or removal of the device.The wire was not removed through the access needle.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16592928
• Report Number: 1820334-2023-00301
• Device Sequence Number: 20105932
• Product Code: DYB
• UDI-Device Identifier: 00827002562011
• UDI-Public: (01)00827002562011(17)250818(10)14909269
• Combination Product (Y/N): N
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2025
• Device Model Number: G56201
• Device Catalogue Number: MPIS-402-NT-U-SST
• Device Lot Number: 14909269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 04/05/2023; 06/16/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/04/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 1 KG