MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PET SYRINGE

Catalog Number	323003
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 bd pet syringe had a broken thumb press and a crushed cap.This was discovered during use.The following information was provided by the initial reporter: material no.: 323003 batch no.: 6294537.It was reported by the consumer that one syringe was found with a broken thumb press and a crushed cap.Verbatim: issue(s): found 1 syringe with plunger rod thumb press broken and same syringe plunger cap crushed.
Additional Manufacturer Narrative
H.6.Investigation: customer returned (1) 1/2cc, 12.7mm, 29g bd pet syringe in an open poly bag from lot#: 6294537.Customer states that the thumb press is broken and the plunger cap is crushed.The returned syringe was examined and exhibited a broken thumb press and a crushed plunger cap.A review of the device history record was completed for batch#: 6294537.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Process summary: the automatic syringe assembly machine feeds 0.5ml syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.There were no quality notifications or log book entries made during the production of this batch.No root cause for this defect can be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that bd pet syringe had a broken thumb press and a crushed cap.This was discovered during use.The following information was provided by the initial reporter: material no: 323003 batch no: 6294537.It was reported by the consumer that one syringe was found with a broken thumb press and a crushed cap.Issue(s): found 1 syringe with plunger rod thumb press broken and same syringe plunger cap crushed.

• Brand Name: BD PET SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9187432
• Report Number: 1920898-2019-01127
• Device Sequence Number: 11414818
• Product Code: FMF
• UDI-Device Identifier: 00382903230020
• UDI-Public: 00382903230020
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 323003
• Device Lot Number: 6294537
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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