MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928856
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9309141, medical device expiration date: 2024-12-31, device manufacture date: 2019-11-05, medical device lot #: 0027932, medical device expiration date: 2025-02-28, device manufacture date: 2020-01-27.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 1.0ml 31ga 8mm 10bag 500 pl/wg had foreign matter on the tip.This was discovered during use.The following information was provided by the initial reporter: material no: 928856 batch no: 9309141, 0027932.It was reported the needles appear bent at the tip prior to injection, the customer can't determine for sure if needle is bent or something is on the tip, sometimes may experience pain during injection.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned as of 14 august 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9309141.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200866010] noted that did not pertain to the complaint.A review of the device history record was completed for batch# 0027932.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200871403] noted that did not pertain to the complaint.H3 other text : see h.10.
Event or Problem Description
It was reported that syringe 1.0ml 31ga 8mm 10bag 500 pl/wg had foreign matter on the tip.This was discovered during use.The following information was provided by the initial reporter: material no: 928856 batch no: 9309141, 0027932.It was reported the needles appear bent at the tip prior to injection, the customer can't determine for sure if needle is bent or something is on the tip, sometimes may experience pain during injection.

• Brand Name: SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10336392
• Report Number: 1920898-2020-00946
• Device Sequence Number: 2697669
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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: Lay User/Patient
• Device Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/17/2020
• 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