MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 25X1 RB; PISTON SYRINGE

Model Number 305270

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe integra 3ml w/ndl 25x1 rb was damaged.The following information was provided by the initial reporter: "got your syringes to use and they broke.".

Event Description

It was reported syringe integra 3ml w/ndl 25x1 rb was damaged.The following information was provided by the initial reporter: "got your syringes to use and they broke".

Manufacturer Narrative

H6: investigation summary: one photo was received showing a loose 3ml integra syringe (p/n 305270) and blisterpak from batch #0266460.The syringe was in a bag labeled "broke", and it could be seen that the syringe had been activated.This was evidenced by the fact that the black stopper nub could be seen in the fluid path, and the cutter being visible beyond the stopper.It was unable to be determined from the photo if the needle had retracted into the syringe.No damage was visible on the syringe.A physical sample is required for a more thorough evaluation.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.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.H3 other text : see h10.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 25X1 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12437195
• MDR Text Key: 271495510
• Report Number: 1213809-2021-00619
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: 30382903052708
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305270
• Device Catalogue Number: 305270
• Device Lot Number: 0266460
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1