MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERHICKMAN CV CATHETER, POLYURETHANE DUAL-LUMEN, 9.5F; CHRONIC CATHETERS

Model Number	0805915
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
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: 05/2022).
Event or Problem Description
It was reported that prior to catheter placement, there was about a four inch cut into the top device.There was no patient contact.
Event or Problem Description
It was reported that prior to catheter placement, there was allegedly about a four inch cut into the top device.There was no patient contact.
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 powerhickman d/l catheter was returned for evaluation.Gross visual evaluations was performed.The investigation is confirmed for the reported tear in packaging issue, as longitudinal cut was noted in the device packaging.The opening appeared to run adjacent to the two examples of the powerhickman catheter printed on the packaging.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.H10: d4 (expiry date: 05/2022).H11: section a through f ¿ the information provide by bd represents all 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.

• Brand Name: POWERHICKMAN CV CATHETER, POLYURETHANE DUAL-LUMEN, 9.5F
• 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: 11964213
• Report Number: 3006260740-2021-02230
• Device Sequence Number: 3193983
• Product Code: LJS
• UDI-Device Identifier: 00801741036699
• UDI-Public: (01)00801741036699
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0805915
• Device Catalogue Number: 0805915
• Device Lot Number: REFN1519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 10/08/2021
• 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