MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1/2ML W/NDL 27X1/2 RB; PISTON SYRINGE

Model Number	305620
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record could not be completed for batch # 6291792 as this is not a lot number from holdrege.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the tip of the syringe 1/2ml w/ndl 27x1/2 rb was clogged before use.The following information was provided by the initial reporter: "clogged syringe.The tip of the syringe.Reported defect: 2 clogged syringe.These syringes have been found clogged when opening the unit.No connection has been done.".
Event or Problem Description
It was reported that the tip of the syringe 1/2ml w/ndl 27x1/2 rb was clogged before use.The following information was provided by the initial reporter: "clogged syringe.The tip of the syringe.Reported defect: 2 clogged syringe.These syringes have been found clogged when opening the unit.No connection has been done.".
Additional Manufacturer Narrative
Correction: the customer provided the incorrect lot# 6291792.After updating the complaint with the correct lot# 6291762, it was realized that the complaint was completed under the incorrect business unit.The complaint has been transferred to the correct business unit.This complaint is cancelled.

• Brand Name: SYRINGE 1/2ML W/NDL 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9718021
• Report Number: 1920898-2020-00138
• Device Sequence Number: 727654
• Product Code: FMF
• UDI-Device Identifier: 30382903056201
• UDI-Public: 30382903056201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: 305620
• Device Catalogue Number: 305620
• Device Lot Number: 6291792
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/06/2020
• 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