MAUDE Adverse Event Report: BD CARIBE LTD. BD BONNANO¿ CATHETER TRAY; CATHETER AND TUBE, SUPRAPUBIC

Model Number	408289
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the batch number involved in this incident is unknown, a device history review cannot be performed.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 3 bd bonnano¿ catheter trays experienced the following information was provided by the initial reporter: the catheter does not glide over the needle on insertion of the drain.Instead, a large amount of force is required to initiate the 'slide' of the catheter, then a sudden loss of resistance (presumably as the overly tight tip of the catheter is no long squeezing on the needle) this results in a 'jolt'.It appears the catheter is too tight around the tip of the needle.Indeed this could be felt when assembling to apparatus.My fear is that this could result in a failure - if the practitioner accidently withdraws the needle they are pulling on, they may then be unable to safely advance the catheter.Or worse, if there is then a compensatory forward motion then the needle could be pushed further into the abdomen than desired.I happened to sit opposite some of the gastro enterology team at lunch today.3 of the 4 had experienced this issue on at least 1 drain in the last 2 weeks.2 of the 3, felt the fault whilst assembling the needle/catheter unit and swapped for another.None of them recorded lot numbers.In the first case chronologically i swapped out and used a different drain and the procedure was completed without incident.In the second case i completed the procedure without adverse incident with the faulty drain.In the most recent case, i have only had reports from the doctors who performed the procedure - i was not present.Reportedly they continued with the 'faulty' drain as no replacement was available and procedure failed and the patient suffered a haematoma, (or perhaps already had a haematoma, which they hit - the dr was a little vague in their reply to me).The patient was then scheduled for an ir dain.I cannot be certain if the mode of failure was due to the reported issue or not.
Event or Problem Description
It was reported that 3 bd bonnano¿ catheter trays experienced the following information was provided by the initial reporter: the catheter does not glide over the needle on insertion of the drain.Instead, a large amount of force is required to initiate the 'slide' of the catheter, then a sudden loss of resistance (presumably as the overly tight tip of the catheter is no long squeezing on the needle) this results in a 'jolt'.It appears the catheter is too tight around the tip of the needle.Indeed this could be felt when assembling to apparatus.My fear is that this could result in a failure - if the practitioner accidently withdraws the needle they are pulling on, they may then be unable to safely advance the catheter.Or worse, if there is then a compensatory forward motion then the needle could be pushed further into the abdomen than desired.I happened to sit opposite some of the gastro enterology team at lunch today.3 of the 4 had experienced this issue on at least 1 drain in the last 2 weeks.2 of the 3, felt the fault whilst assembling the needle/catheter unit and swapped for another.None of them recorded lot numbers.In the first case chronologically i swapped out and used a different drain and the procedure was completed without incident.In the second case i completed the procedure without adverse incident with the faulty drain.In the most recent case, i have only had reports from the doctors who performed the procedure - i was not present.Reportedly they continued with the 'faulty' drain as no replacement was available and procedure failed and the patient suffered a haematoma, (or perhaps already had a haematoma, which they hit - the dr was a little vague in their reply to me).The patient was then scheduled for an ir dain.I cannot be certain if the mode of failure was due to the reported issue or not.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 1354605.D4: medical device expiration date: 31-dec-2026.H4: device manufacture date: 15-feb-2022.H6: investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation and cannot verify the reported issue.Since an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing records were reviewed for the incident lot and no discrepancy or nonconformance were identified that could have contributed to the reported condition.A review of the device history record was performed and no quality issues were found during inspection.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD BONNANO¿ CATHETER TRAY
• Common Device Name: CATHETER AND TUBE, SUPRAPUBIC
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15089867
• Report Number: 2618282-2022-00036
• Device Sequence Number: 4055745
• Product Code: FEZ
• UDI-Device Identifier: 00382904082895
• UDI-Public: 00382904082895
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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 Model Number: 408289
• Device Catalogue Number: 408289
• Device Lot Number: 1354605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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