MAUDE Adverse Event Report: BD CARIBE LTD. ADAPTER CATHETER S/SU; ANESTHESIA CONDUCTION CATHETER

Model Number	403250
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that adapter catheter s/su leaked.The following information was provided by the initial reporter: material no.: 403250, batch no.: 9352479.It was reported that the dye is coming out of the side when the catheter is inserted.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Investigation conclusion: examination of the product involved may provide clarification as to the cause for the reported failure.Root cause description: based on the quality team's investigation, the root cause of this incident cannot be determined.Root caused cannot be associated with the material nor the manufactured process since no indications from the manufacturing records review of situations that could contribute to the customer reported failure.The catheter adapter comply with inspections requirement and were found in accordance with bd specifications.Rationale: per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.H3 other text : see h.10.
Event or Problem Description
It was reported that adapter catheter s/su leaked.The following information was provided by the initial reporter: material no.: 403250, batch no.: 9352479.It was reported that the dye is coming out of the side when the catheter is inserted.

• Brand Name: ADAPTER CATHETER S/SU
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 10962225
• Report Number: 2618282-2020-00103
• Device Sequence Number: 4330189
• Product Code: BSO
• UDI-Device Identifier: 30382904032501
• UDI-Public: 30382904032501
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K850505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: Other
• Device Expiration Date: 12/31/2024
• Device Model Number: 403250
• Device Catalogue Number: 403250
• Device Lot Number: 9352479
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1