MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿ HYPODERMIC NEEDLE

Catalog Number	300255
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7051429.Medical device expiration date: 2022-02-28.Device manufacture date: 2017-03-09.Medical device lot #: 7051442.Medical device expiration date: 2022-02-28.Device manufacture date: 2017-03-09.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd hypoint¿ hypodermic needle had foreign matter on the needle before use.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: in evaluating the returned photos, bd was unable to determine whether it is a foreign matter.In evaluation of returned samples, bd was able to observe the fm.Inspection was performed as the fm size is found to be <0.05mm2 which is within specification.Ftir analysis was performed on the fm and observed to be protein.Based on dhr record, there are no abnormalities observed.Protein observed maybe produced outside the manufacturing facility as this is not observe in manufacturing process.Hence, root cause is not established.No capa is required as awareness training on the complaint has been performed on 7 december 2018 which happened after the affected batches produced.
Event or Problem Description
It was reported that bd hypoint¿ hypodermic needle had foreign matter on the needle before use.No serious injury or medical intervention was reported.

• Brand Name: BD HYPOINT¿ HYPODERMIC NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8125343
• Report Number: 8041187-2018-00442
• Device Sequence Number: 267991
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070440
• 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): 12/12/2018

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: 300255
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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