MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 20GX1.00IN STRAIGHT BC; SYRINGE/NEEDLE

Catalog Number	386803
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	06/06/2019
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 cathena 20gx1.00in straight bc.The following information was provided by the initial reporter, "user noticed a small plastic piece on the needle before use.".
Event or Problem Description
It was reported that foreign matter was found before use with a cathena 20gx1.00in straight bc.The following information was provided by the initial reporter, "user noticed a small plastic piece on the needle before use.".
Additional Manufacturer Narrative
Investigation:1 photo was returned for evaluation.It was observed that there was foreign matter on the cannula.The complaint is confirmed and product is out of specification.The investigation was not able to confirm what has cause the nonconformance as the pictures are unclear.A review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance.No abnormality was observed during the production of the reported batch.Hence, root cause is unable to be determined.

• Brand Name: CATHENA 20GX1.00IN STRAIGHT BC
• Common Device Name: SYRINGE/NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8744478
• Report Number: 8041187-2019-00499
• Device Sequence Number: 16566651
• Product Code: FMF
• UDI-Device Identifier: 00382903868032
• UDI-Public: 382903868032
• 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): 07/18/2019

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: 10/31/2021
• Device Catalogue Number: 386803
• Device Lot Number: 8297520
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/19/2019
• 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