MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY; CATHETER,INTRAVASCULAR

Model Number	4251628-02
Medical Device Problem Codes	Fail-Safe Problem (2936); Device Handling Problem (3265)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported event are being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by the user facility: the safety on this needle did not activate and this resulted in a needle stick and exposure to one of the nurses.While holding pressure on the site, i attempted to move the needle away from the patient and did not notice that the needle tip was not covered by the safety shield.I grabbed the needle at the hub with my thumb and index finger but was stuck in my ring finger of the same hand.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) used sample, and eighty-three (83) unused samples were received for evaluation.Seven (7) of the unused samples were from the reported batch of 20f10g8272 and seventy-six (76) of the unused samples were from batch 20h12g8302.When the used sample was visually inspected, it was observed that the safety clip was dislodged, however the sample was tested and met all specifications.This product is subjected to a 100% inspection by an in-line vision system that is calibrated and subjected to regular verifications to ensure it is functioning properly.The defect observed in the returned sample would have been detected and rejected by the in-line vision system.All eighty-three (83) unused samples were functionally tested, and all eighty-three (83) samples functioned as intended with the safety clip engaging and covering the needle tip after withdrawal.Review of the device history records were performed for the reported batch number and for batch 20h12g8302, and did not reveal any abnormalities or non-conformances of this nature.Based on the results of the investigation, the defect observed could not be traced back to the manufacturing process, however no conclusions can be made regarding the cause of the reported event.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INTROCAN SAFETY
• Common Device Name: CATHETER,INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 11260008
• Report Number: 9610825-2021-00006
• Device Sequence Number: 790506
• Product Code: FOZ
• UDI-Device Identifier: 04046963166021
• UDI-Public: (01)04046963166021
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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 Expiration Date: 08/01/2025
• Device Model Number: 4251628-02
• Device Catalogue Number: 4251628-02
• Device Lot Number: 20H12G8302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1