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

Model Number	G47945
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation = lab manager.Pma/510(k) number = k171275.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a left upper arm fistulogram involving a patient of unknown age and gender, a micropuncture traditionless pediatric access set introducer separated.An unknown 20 cc syringe was attached to the 4 french introducer.It was reported that the introducer became twisted.When the physician disconnected the syringe, the micropuncture introducer broke off.A portion of the device remained in the patient's left upper arm.The physician was able to snare the broken piece from the access site.There was reportedly no injury to the patient.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.
Additional Manufacturer Narrative
Investigation ¿ evaluation reviews of the dimensional verification, complaint history, device history record, drawing, manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one micropuncture transitionless pediatric access set was returned to cook for investigation in two sections.The proximal section was measured 2cm and a kink was noted 1.2cm from the distal end of the luer lock adapter.The distal portion measured 8.4cm and the distal tip was jagged.The separation point between the two returned portions was twisted and torn.The distal section was very twisted and the distal 4.2cm was flattened.A kink was noted 4.1cm from the proximal separation site.Additionally, biomatter was noted throughout the device.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record did reveal some nonconforming events which could contribute to this failure mode.However, these nonconformances were caught and scrapped prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS PEDIATRIC ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8752610
• Report Number: 1820334-2019-01590
• Device Sequence Number: 13934498
• Product Code: DYB
• UDI-Device Identifier: 00827002479456
• UDI-Public: (01)00827002479456(17)220411(10)9661266
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 04/11/2022
• Device Model Number: G47945
• Device Catalogue Number: MPIS-401-PED-SST
• Device Lot Number: 9661266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention