MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL W/O DN; PISTON SYRINGE

Catalog Number 309628

Device Problems Break (1069); Crack (1135); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the syringe 1ml ll w/o dn experienced a general malfunction.The following information was provided by the initial reporter: material no.309628, batch no.8298782."it was reported that a 1cc syringe was broken and the shaft separated from the plunger." response from customer to information request: was the syringe broken because the plunger separates from the shaft, or was there a different defect? "there was a slight crack in the shaft of the syringe that was difficult to see, it led to the plunger being loose and when they pulled the plunger it came all the way out of the shaft.".

Event Description

It was reported that the syringe 1ml ll w/o dn experienced a general malfunction.The following information was provided by the initial reporter: material no.309628 batch no.8298782."it was reported that a 1cc syringe was broken and the shaft separated from the plunger." response from customer to information request: was the syringe broken because the plunger separates from the shaft, or was there a different defect? "there was a slight crack in the shaft of the syringe that was difficult to see, it led to the plunger being loose and when they pulled the plunger it came all the way out of the shaft.".

Manufacturer Narrative

Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.According to verbatim, the complaint appears to also be for the absence of retaining ring in the syringe barrel.This product does not have a retaining ring by design according to its product specification.The design of the product has not changed since october 2008 when the product was first introduced.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: SYRINGE 1ML LL W/O DN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8562241
• MDR Text Key: 147198253
• Report Number: 1213809-2019-00482
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 309628
• Device Lot Number: 8298782
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other