MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 18X1IN BLUNT FILL; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number	305181
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: one sample was received and evaluated.It came in an opened packaging blister with needle assembly with a plastic shield.A visual inspection was performed with a 10x magnifier lens.The needle has white epoxy towards the needle tip.It is about ¼¿ long.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the investigation and sample analysis the symptom reported by the customer is confirmed.This lot was produced for 3.49 mm units; therefore, the cpm is 0.29.We will continue monitoring and trending this lot for this symptom.Root cause description: a potential root cause can be attributed to the needle assembly line.The plastic hub is placed under the cannulator; then, the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it; after that, a plastic hub is assembled.In this case, a jam may have occurred at the cannulator inducing the excess of white epoxy on the needle.Rationale: capa not required at this time.
Event or Problem Description
It was reported that needle 18 x 1 in blunt fill had foreign matter on the needle.This was discovered before use.The following information was provided by the initial reporter: material no.305181, batch no.9350653.It was reported that foreign matter was found on the needle inside the package.

• Brand Name: NEEDLE 18X1IN BLUNT FILL
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10411667
• Report Number: 1911916-2020-00745
• Device Sequence Number: 2392379
• Product Code: GAA
• UDI-Device Identifier: 30382903051817
• UDI-Public: 30382903051817
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/05/2020

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: 02/28/2025
• Device Model Number: 305181
• Device Catalogue Number: 305181
• Device Lot Number: 9350653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/14/2020
• 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