MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 26X1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305111
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a device history record review was completed for provided material number 305111 and lot number 9193541.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, two hundred seventeen physical samples and four photos were received for evaluation by our quality team.The samples came in sealed package blisters.A visual inspection was performed with a 10x magnifiers lens and no embedded degraded resin or any other defect or imperfection was observed.All the photos show a needle assembly with the plastic shield.One photo shows a plastic shield with embedded foreign matter.The remaining three photos show the needle hub with embedded foreign matter.Investigation conclusion: based on the investigation with the photo sample analysis the symptom reported by the customer is confirmed.There are quality controls currently in place to detect this type of defect during the production process.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Root cause description: it could be possible for this defect to occur intermittently or during the startup of the molding process.Degraded resin inherently builds up in the hot-runner system, can break loose and be molded into components.Rationale: further action has not been determined necessary at this time.Capa not required at this time.
Event or Problem Description
It was reported that needle 26x1/2 rb had stains in the caps.The following information was provided by the initial reporter: material no: 305111, batch no: 9193541.It was reported stains in the caps.Verbatim: per customer's e-mail sent to us on (b)(6) 2021.What is the date of event? the items were identified on (b)(6) 2021.Was anyone hurt? not at this moment, this was identified in the production line.Do you have patient identifiers? not applicable, identified in the production line.How many needles were with stains? the customer sorted 1000 units and found 220 with issues.

• Brand Name: NEEDLE 26X1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11270079
• Report Number: 1911916-2021-00075
• Device Sequence Number: 1219823
• Product Code: FMI
• UDI-Device Identifier: 00382903051113
• UDI-Public: 00382903051113
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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: Other
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 305111
• Device Lot Number: 9193541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1