MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 23X1 RB; PISTON SYRINGE

Model Number 305271

Device Problems Break (1069); Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the syringe integra 3 ml w/ndl 23 x 1 rb experienced difficult plunger movement and device damage/deformation.Product defects were noted during use.The following information was provided by the initial reporter: material no.305271, batch no.Unknown (provided: 9093628).No adverse event.Plunger is failing and medication is getting lost.Customer doesn't know how much medication he was administered in his last three uses.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see h.10.

Event Description

It was reported that the syringe integra 3ml w/ndl 23x1 rb experienced difficult plunger movement and device damage/deformation.Product defects were noted during use.The following information was provided by the initial reporter: material no.305271, batch no.Unknown (provided: 9093628).No adverse event.Plunger is failing and medication is getting lost.Customer doesn't know how much medication he was administered in his last three uses.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 23X1 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10452207
• MDR Text Key: 205315919
• Report Number: 1213809-2020-00570
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: 30382903052715
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 305271
• Device Catalogue Number: 305271
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other