MAUDE Adverse Event Report: BD CARIBE LTD. KIT PERISAFE 18GA 3-1/2IN WEISS; ANESTHESIA CONDUCTION KIT

Model Number	400273
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the kit perisafe 18ga 3-1/2in weiss experienced the catheter breaking apart.An x-ray was administered to the patient in an attempt to locate a broken piece of the device believed to be embedded within the patient.The following information was provided by the initial reporter: catheter broken while reinserting in the patient.The dr at the hospital was using perisafe on the patient, they tried to reinsert in 2nd attempt while reinserting they noticed that 2-3 cm of catheter was broken and tried to locate the broken part.They tried to locate by taking x-ray, ct of lumbar region and ultrasound but could not locate the same.However they confirmed the patient is doing fine as of now.They completed the procedure by using another unit.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 8115818.D4: medical device expiration date: 5/31/2023.H4: device manufacture date: 6/1/2018.D9: device available for eval?: yes.D9: returned to manufacturer on: 9/21/2021.H6: investigation: based on the sample provided to bd for evaluation, the reported condition was verified.It was observed under magnification that the tip of the catheter was broken (torn) at an angle similar to a bevel cut (not a straight cut).In addition, five to six consecutive scratches can be observed near the broken tip.The scratches are on the outside of the tube and are located only on the top side.Scratches do not go around the tube.The only scratches seen throughout the catheter are the ones identified on the tip next to the torn part (tip).A review of the device history record was performed, and no quality issues were found during production.Upon further assessment, it was noted that shearing of an epidural catheter could occur if the catheter was placed throughout the needle or withdrawn, and during the procedure, the catheter could have bent.The act of withdrawing or pulling the catheter could result in the catheter becoming sheared.
Event or Problem Description
It was reported that the kit perisafe 18ga 3-1/2in weiss experienced the catheter breaking apart.An x-ray was administered to the patient in an attempt to locate a broken piece of the device believed to be embedded within the patient.The following information was provided by the initial reporter: catheter broken while reinserting in the patient.The dr at the hospital was using perisafe on the patient, they tried to reinsert in 2nd attempt while reinserting they noticed that 2-3 cm of catheter was broken and tried to locate the broken part.They tried to locate by taking x-ray, ct of lumbar region and ultrasound but could not locate the same.However they confirmed the patient is doing fine as of now.They completed the procedure by using another unit.

• Brand Name: KIT PERISAFE 18GA 3-1/2IN WEISS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12477868
• Report Number: 2618282-2021-00054
• Device Sequence Number: 3780269
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K953790
• 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): 10/25/2021

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: 05/31/2023
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 8115818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown