MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN PEDIATRIC CV CATHETER, DUAL-LUMEN, 9F; CHRONIC CATHETERS

Model Number	0600580
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Flush (1251); Fracture (1260); Obstruction of Flow (2423)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2024).
Event or Problem Description
It was reported that some time post catheter placement, the catheter was allegedly broken.It was further reported that contrast medium allegedly leaked.Patient experienced extravasation.Patient current status was unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 9fr hickman d/l catheter with two three-way valves attached to both luers was returned for evaluation.Functional, gross visual and microscopic visual evaluation were performed.A complete, diagonal break was noted approximately 25.3 cm from the distal end of the y-body.However, striations were observed on the surface of the complete diagonal break, which also appeared smooth.The investigation is inconclusive for the reported catheter break, leak, catheter occlusion and difficult to flush issues, as the distal catheter segment was not returned for evaluation, the exact circumstances at the time of the reported event are unknown and the sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm this event occurred under clinical conditions.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: the catalog number identified in section d4 has not been cleared in the us but is similar to the hickman pediatric cv catheter, dual-lumen, 9f products that are cleared in the us.The pro code and 510 k number for the hickman pediatric cv catheter, dual-lumen, 9f products are identified in d2 and g4.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.H3 other text : see h10.
Event or Problem Description
It was reported that some time post catheter placement, the catheter was allegedly broken.It was further reported that contrast medium allegedly leaked.Reportedly there was difficulty in flushing the catheter and thrombus at the tip was observed.Patient experienced extravasation.Patient current status was unknown.

• Brand Name: HICKMAN PEDIATRIC CV CATHETER, DUAL-LUMEN, 9F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12201049
• Report Number: 3006260740-2021-02869
• Device Sequence Number: 14330008
• Product Code: LJS
• UDI-Device Identifier: 00801741051883
• UDI-Public: (01)00801741051883
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 0600580
• Device Catalogue Number: 0600580CE
• Device Lot Number: HUEV1438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 YR