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	12/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7051492, medical device expiration date: 2022-02-28, device manufacture date: 2017-03-15.Medical device lot #: 7075224, medical device expiration date: 2022-03-31, device manufacture date: 2017-04-11.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 white foreign matter was found near the epoxy and on the needle hub of the bd hypoint¿ hypodermic needles after removing their needle shields.Lot #s 7051492 and 7075224 respectively were reported to have been involved in this event, but the number of occurrences for each is unknown.
Event or Problem Description
It was reported that white foreign matter was found near the epoxy and on the needle hub of the bd hypoint¿ hypodermic needles after removing their needle shields.Lot #s 7051492 and 7075224 respectively were reported to have been involved in this event, but the number of occurrences for each is unknown.
Additional Manufacturer Narrative
Investigation summary: a review of the device history record revealed no irregularities during the manufacture of the reported lot.From the returned samples, fm1 can be observed.Fm 2 and 3 is not clear enough to identify the fm.Returned samples able to observe only fm1 which is placed on the glass plate.The fm size did not pass criteria for bdj loose fm outside hub (>0.05mm2 and <0.1mm2).Ftir analysis was performed on fm1 and observed inorganic material.It is suspected that the inorganic material might be from environment.-will communicate to manufacturing associates on the awareness of this complaint emphasize on gmp.

• Brand Name: BD HYPOINT¿ HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8237059
• Report Number: 8041187-2018-00514
• Device Sequence Number: 1594067
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: 300255
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/07/2019
• 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