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

Model Number 305271

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

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an unspecified number of syringes integra 3ml w/ndl 23x1 rb experienced missing needles after medication injection during use.The lay user/patient received medical intervention, receiving an x ray scan in an attempt to locate the missing needle, which was not found.The needle was searched for "all over the floor" as well and was still not found.The following information was provided by the initial reporter: material no: 305271, batch no: 8092760.Spouse stated, was not aware the needle retracted.Stated, she would be comfortable knowing the needle did retract and would like feedback after product evaluation is complete.Stated, an x-ray was taken but no needle was recovered.Customer called to report that her husband was giving himself a shot with our bd needle and that after he was finished and pulled the needle out the needle was gone.The needle disappeared, he went to the urgent care on saturday (same day as incident date), they took x-rays needle was not found.She looked all over the floor and still no needle found.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/14/2020.H.6.Investigation: one 3ml integra syringe in an opened blister pack from batch 8092760 (p/n 305271) was received and evaluated.It was observed the plunger rod was fully depressed and the retraction mechanism was activated.The hub was removed, and the cannula appeared to safely concealed inside the plunger rod as expected.No defects were observed.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.H3 other text : see h.10.

Event Description

It was reported that an unspecified number of syringes integra 3ml w/ndl 23x1 rb experienced missing needles after medication injection during use.The lay user/patient received medical intervention, receiving an x ray scan in an attempt to locate the missing needle, which was not found.The needle was searched for "all over the floor" as well and was still not found.The following information was provided by the initial reporter: material no: 305271 batch no: 8092760.Spouse stated, was not aware the needle retracted.Stated, she would be comfortable knowing the needle did retract and would like feedback after product evaluation is complete.Stated, an x-ray was taken but no needle was recovered.Customer called to report that her husband was giving himself a shot with our bd needle and that after he was finished and pulled the needle out the needle was gone.The needle disappeared, he went to the urgent care on saturday (same day as incident date), they took x-rays needle was not found.She looked all over the floor and still no needle found.

• 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: 10616299
• MDR Text Key: 209542722
• Report Number: 1213809-2020-00684
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: (01)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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 305271
• Device Catalogue Number: 305271
• Device Lot Number: 8092760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention