MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	4251644-02
Medical Device Problem Codes	Fail-Safe Problem (2936); Device Handling Problem (3265)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/17/2020
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 not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.It should be noted that although the exact batch number is unknown, the following potential batch numbers were provided: lot 0061735860; manufactured: 10/05/2020, expiration: 09/30/2025.Lot 0061727004; manufactured: 09/23/2020, expiration: 08/31/2025.
Event or Problem Description
As reported by the user facility: "a nurse started an iv and it did not work.The safety clip deployed.While cleaning up, the nurse was stuck in the finger by the needle.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400499104.One used sample without packaging was returned for evaluation.The complaint sample was reviewed by the product smes and extensive damage was noted on the clip.The clip appeared to be crushed to the extent where the arms were forced open.While damage can occur during the processing of the piece, it is unlikely that the defect was caused by the process.All units are 100% visually inspected by the clip inspection station.A piece with that amount of damage would be rejected immediately.Additionally, the needle guard would not fit over the clip if it was damaged in the way that was observed.Therefore, the component would not have passed through the guard load station without triggering a fault.It is the conclusion of the smes that the damage to the clip occurred outside of the b.Braun manufacturing facility.The reported defect was not confirmed.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: INTROCAN SAFETY
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 11196287
• Report Number: 2523676-2021-00012
• Device Sequence Number: 3700979
• Product Code: FOZ
• UDI-Device Identifier: 04046963166007
• UDI-Public: 04046963166007
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 Model Number: 4251644-02
• Device Catalogue Number: 4251644-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1