MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN,12F; CHRONIC CATHETERS

Model Number	0600620
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Infiltration into Tissue (1931)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2024).Device not returned.
Event or Problem Description
It was reported that some time post catheter placement procedure, the patient allegedly experienced hematoma and local infiltration.Patient current status is unknown.
Event or Problem Description
It was reported that some time post catheter placement procedure, the patient allegedly experienced hematoma and local infiltration.Patient current status is unknown.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.Three electronic photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as the provided photos are not sufficient enough to confirm the issue.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 01/2024) the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one hickman d/l catheter was returned for evaluation and three electronic photos were provided for review.Gross visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the identified fracture issue as a longitudinal split was noted approximately 2.5cm proximal to the distal end of the catheter.Furthermore, the relation of identified device fracture problem to the reported clinical condition cannot be confirmed due to lack of evidence.Therefore, the clinical conditions alleged in the complaint is inconclusive.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 01/2024), g3.H11: h6 (device, method, result).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that some time post catheter placement procedure, the patient allegedly experienced hematoma and local infiltration.Patient current status is unknown.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN,12F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12437403
• Report Number: 3006260740-2021-03702
• Device Sequence Number: 11676285
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2021

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 Model Number: 0600620
• Device Catalogue Number: 0600620
• Device Lot Number: HUDX2549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 09/23/2021; 11/10/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/27/2021; 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2019
• 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: Other
• Patient Sex: Female