MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 REPAIR WHITE ADAPTER LEG; PORT AND CATHETER ACCESSORIES

Model Number	0601680
Medical Device Problem Codes	Moisture Damage (1405); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.Expiration date: 09/2023.
Event or Problem Description
It was reported that prior to a chronic catheter placement procedure, the packaging allegedly had moisture damage.It was further reported that the device was allegedly contaminated with dirt.There was no patient contact.
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 sample was not returned for evaluation, two electronic photos were provided for review.The photo shows outer packaging of the cv repair kit.Manufacturing site evaluation of the sample found that the packaging had moisture stains and these stains were present throughout the packaging and through the unit label.The investigation is confirmed for the reported moisture damage issue as water stains were noted on the outer package.However the investigation is inconclusive for the reported contamination issue.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.D4 (expiration date: 09/2023).H11: section a through f ¿ the information provided 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.H3 other text : device not returned.
Event or Problem Description
It was reported that prior to a chronic catheter placement procedure, the packaging allegedly had moisture damage.It was further reported that the device was allegedly contaminated with dirt.There was no patient contact.

• Brand Name: REPAIR WHITE ADAPTER LEG
• Common Device Name: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16191616
• Report Number: 3006260740-2022-06081
• Device Sequence Number: 5794973
• Product Code: LJS
• UDI-Device Identifier: 00801741036415
• UDI-Public: (01)00801741036415
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K830406
• 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
• Report Date (Section B): 03/06/2023

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: 0601680
• Device Catalogue Number: 0601680
• Device Lot Number: REFX4542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2021
• 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
• Patient Sex: Unknown