MAUDE Adverse Event Report: BD CARIBE LTD. TRAY BONANNO CATHETER S/SU; SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES

Catalog Number	408289
Medical Device Problem Codes	Break (1069); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a broken catheter occurred during use with a tray bonanno catheter s/su.The following information was provided by the initial reporter, "cnm informed me that a senior register was doing an abdominal tap to remove fluid from patient abdominal when the catheter kinked.Tried 2nd catheter and tip broke off.All off device retrieved from patient.".
Additional Manufacturer Narrative
Investigation: bd has been provided with 2 samples for catalog 408289 to investigate for this record.Sample received was not the actual sample involved in the reported complaint.It was a representative sample from the lot 8008682 reported in this complaint.It was also received in the same package another sample from a different lot 7137953.Two samples were received, just one a representative sample of the lot reported in the complaint.Unfortunately, bd was unable to verify the reported issue as no malfunctions or non-conformance's were identified when tested by the qc inspectors.With the information provided, the most probable root cause is an incorrect use of the material.As per dhr review there were no issues reported that could have contributed to the reported condition.No ncmrs were generated for this batch.No previous history of complaints related to tray bonanno catheter were identified.
Event or Problem Description
It was reported that a broken catheter occurred during use with a tray bonanno catheter s/su.The following information was provided by the initial reporter, "cnm informed me that a senior register was doing an abdominal tap to remove fluid from patient abdominal when the catheter kinked.Tried 2nd catheter and tip broke off.All off device retrieved from patient.".

• Brand Name: TRAY BONANNO CATHETER S/SU
• Common Device Name: SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8853041
• Report Number: 2618282-2019-00232
• Device Sequence Number: 16781300
• Product Code: FEZ
• UDI-Device Identifier: 00382904082895
• UDI-Public: 00382904082895
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 408289
• Device Lot Number: 8008682
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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