MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Model Number	305272
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical 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 or Problem Description
It was reported that the detachable needle broke off from the bd integra¿ syringe into the consumer's buttocks while injecting testosterone.The consumer visited the emergency room and an x-ray was taken, but the broken needle piece was not found.The following information was provided by the initial reporter: "consumer stated, he thinks needle broke off in him when his wife was administering his testosterone injection.Stated, spent over 2 hours in emergency room.Stated, x-ray taken and they were not able to locate a needle inside his buttocks stated, he was never told how to use syringe by his pharmacist or doctor consumer stated, he and his wife are elderly and cannot afford out of pocket on going to emergency room.I explained, there is not guarantee but he can submit out of pocket and eob's, (explanation of benefits) to management for consideration.I explained, the product is a retractable safety syringe".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/10/2020.H.6.Investigation: one loose 3ml integra was received and evaluated.It was observed the plunger rod had been pulled back and the spring was loose inside the barrel.The cannula appeared to retract as expected and was concealed inside the plunger rod.The reported defect was not identified in the samples received.Lot number is unknown; therefore lot history could not be performed.H3 other text : see h.10.
Event or Problem Description
It was reported that the detachable needle broke off from the bd integra¿ syringe into the consumer's buttocks while injecting testosterone.The consumer visited the emergency room and an x-ray was taken, but the broken needle piece was not found.The following information was provided by the initial reporter: "consumer stated, he thinks needle broke off in him when his wife was administering his testosterone injection.Stated, spent over 2 hours in emergency room.Stated, x-ray taken and they were not able to locate a needle inside his buttocks.Stated, he was never told how to use syringe by his pharmacist or doctor consumer stated, he and his wife are elderly and cannot afford out of pocket on going to emergency room.I explained, there is not guarantee but he can submit out of pocket and eob's, (explanation of benefits) to management for consideration.I explained, the product is a retractable safety syringe".

• Brand Name: BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10946706
• Report Number: 1213809-2020-00873
• Device Sequence Number: 19593979
• Product Code: MEG
• UDI-Device Identifier: 30382903052722
• UDI-Public: 30382903052722
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 305272
• Device Catalogue Number: 305272
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention