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

Catalog Number	4251644-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: "a catheter broke when being removed from a patient.The catheter was completely removed from the patient using the normal technique of removing catheters by applying pressure to the vein.When the catheter was removed, it was noticed that the catheter was broken.The patient was safely canalized in another vein in the other arm.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) unused catheters with packaging were returned for evaluation.Photos were also provided.The samples were visually inspected per specification, and no defects were noted.In the photo, it was noted that the needle was pierced through the catheter.This defect could not have occurred during manufacturing, as our process would have caused the unit to fail at this trim length.Therefore, the reported defect was not confirmed.Retained units for the reported batch number were inspected, and no defects were noted.The retained units were found to meet specifications.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.

• 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: 9273676
• Report Number: 2523676-2019-00213
• Device Sequence Number: 16555590
• Product Code: FOZ
• UDI-Device Identifier: 04046963166007
• UDI-Public: 04046963166007
• Combination Product (Y/N): N
• PMA/510(K) Number: K020785
• 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): 01/09/2020

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: 03/31/2024
• Device Catalogue Number: 4251644-02
• Device Lot Number: 0061665446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR