MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER; INTERVASCULAR CATHETER

Catalog Number	386804
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter was found before use with a bd cathena¿ safety iv catheter.The following information was provided by the initial reporter, "contaminated cathena safety cannula was found in av supply.It contains what appears to be a hair, which has been sealed within the packaging.".
Additional Manufacturer Narrative
H.6.Investigation: 2 photos were returned for evaluation.A hair-liked foreign matter (fm) was observed from the returned photos.The hair-like foreign matter is most like be a thread hair.Hair found in the sealed packaging.This could have probably caused by improper gowining of the hair.The manufacturing process was reviewed.This most likely could have occurred at the primary packaging.Dhr was performed and no quality notification was raised for a similar nonconformance during the production of the batch.
Event or Problem Description
It was reported that foreign matter was found before use with a bd cathena¿ safety iv catheter.The following information was provided by the initial reporter, "contaminated cathena safety cannula was found in av supply.It contains what appears to be a hair, which has been sealed within the packaging.".

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8967702
• Report Number: 8041187-2019-00708
• Device Sequence Number: 14099597
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/12/2019

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 386804
• Device Lot Number: 8060119
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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