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

Catalog Number 305271

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe integra 3ml w/ndl 23x1 rb needle was thought to have been broken off inside the patient's leg.The patient went to the er and got an x-ray, which confirmed that the needle was not inside the patient's leg.The following information was provided by the initial reporter: consumer reported found 2 integra syringes with issues - did not realize the syringe retracts into the syringe.Used first syringe from this supply thought the needle broke off in his leg (b)(6)2021.Went to the emergency room on this day they completed x-ray and did not locate the needle in leg.Went home and took syringe apart and found the needle retracted within the plunger rod.

Manufacturer Narrative

H6: investigation summary: 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.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.

Event Description

It was reported that syringe integra 3ml w/ndl 23x1 rb needle was thought to have been broken off inside the patient's leg.The patient went to the er and got an x-ray, which confirmed that the needle was not inside the patient's leg.The following information was provided by the initial reporter: consumer reported found 2 integra syringes with issues - did not realize the syringe retracts into the syringe.Used first syringe from this supply thought the needle broke off in his leg (b)(6) 2021.Went to the er on this day they completed x-ray and did not locate the needle in leg.Went home and took syringe apart and found the needle retracted within the plunger rod.

• 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: 11970821
• MDR Text Key: 259461884
• Report Number: 1213809-2021-00412
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382903052714
• UDI-Public: 00382903052714
• 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: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 305271
• Device Lot Number: 8309642
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention