MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 21X1 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305915
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.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 needle sftygld 21x1 rb tw had foreign matter.The following information was provided by the initial reporter: it was reported that the nurse caught the foreign matter before using on the patient.
Additional Manufacturer Narrative
H.6.Investigation: two photos and four packages were received.The packages were sealed needles from smiths medical and were not evaluated.One photo showed the top web of a package showing it to be from batch #0269688 (p/n 305915).One photo showed a closeup of a needle with a small fiber of foreign matter extending from the needle body.Another small fiber of foreign matter could be seen extending from the needle bevel.The foreign matter appeared to be larger enough to be considered defective per product specification.Potential root cause for the foreign matter defect is associated with the needle supplier¿s manufacturing process.The photos will be forwarded to the needle supplier for further evaluation and investigation.Further investigation performed.2 photos were provided.One photo shows a needle assembly out of the packaging blister with no plastic shield.The needle has debris one at the middle and the other one at the needle tip.From the photo it is unclear the type of material of the debris.The second photo shows a packaging blister top web.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.With no sample analysis a probable root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that needle sftygld 21x1 rb tw had foreign matter.The following information was provided by the initial reporter: it was reported that the nurse caught the foreign matter before using on the patient.

• Brand Name: NEEDLE SFTYGLD 21X1 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11995560
• Report Number: 1213809-2021-00424
• Device Sequence Number: 13683476
• Product Code: FMI
• UDI-Device Identifier: 00382903059157
• UDI-Public: 00382903059157
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 305915
• Device Lot Number: 0269688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1