MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ BC STRAIGHT CATHETER; INTRAVASCULAR CATHETER

Catalog Number	386804
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that the bd cathena¿ bc straight catheter has been found experiencing two occurrences of containing foreign matter before use.The following has been provided by the initial reporter: as above.Plastic bit noted by users before use.
Additional Manufacturer Narrative
H.6.Investigation: photo evaluation: 2 photos were returned for evaluation.From the returned photos, fm was observed on the cannula.The investigation was not able to confirm the what customer had experienced as the returned photos are unclear.Hence, root cause is unable to be determined.Dhr could not be performed due to unknown lot#.
Event or Problem Description
It has been reported that the bd cathena¿ bc straight catheter has been found experiencing two occurrences of containing foreign matter before use.The following has been provided by the initial reporter: as above.Plastic bit noted by users before use.

• Brand Name: BD CATHENA¿ BC STRAIGHT CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8982794
• Report Number: 8041187-2019-00713
• Device Sequence Number: 13544398
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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 Catalogue Number: 386804
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other