MAUDE Adverse Event Report: PENCAN; SPINAL ANESTHESIA KIT

Model Number	333868
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: it was stated that the needle bent during insertion.When the needle was removed a bent was observed and upon touching the needle, it broke off from the hub.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used kit with packaging confirming the reported lot was returned for evaluation.Only the needles were retuned in the kit packaging.The returned needles were visually evaluated per specification.It was noted that the guide needle was broken off at the hub.The sample and all available information were forwarded to the manufacturer for further evaluation.Based on the manufacturers investigation results is was determined that the break likely occurred due to wrong handling.The event description confirms that "the needle bent during insertion.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: PENCAN
• Common Device Name: SPINAL ANESTHESIA KIT
• MDR Report Key: 9884787
• Report Number: 2523676-2020-00090
• Device Sequence Number: 492514
• Product Code: OFU
• UDI-Device Identifier: 04046964180866
• UDI-Public: 04046964180866
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 333868
• Device Catalogue Number: 333868
• Device Lot Number: 0061715016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1