MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T W/NDL 26X5/8 RB; PISTON SYRINGE

Catalog Number 309597

Device Problems Break (1069); Entrapment of Device (1212); Product Quality Problem (1506); Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7309904; medical device expiration date: 2022-10-31; device manufacture date: 2017-11-05; medical device lot #: 8059526; medical device expiration date: 2023-02-28; device manufacture date: 2018-02-28.

Event Description

It was reported that an unspecified number of syringe 1ml s/t w/ndl 26x5/8 rb experienced needle breakage inside patient.The following information was provided by the initial reporter: material no.309597, batch no.7309904 and 8059526.(2 out of 2).Patient claims that syringe and needle provided in the kit for injection is horrible.Has trouble drawing up and states needles have previously come off syringe and got stuck in his leg.

Manufacturer Narrative

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.A device history record review showed no rejected inspections or quality issues during the production of the two provided lot number(s) that could have contributed to the reported defect.

Event Description

It was reported that an unspecified number of syringe 1ml s/t w/ndl 26x5/8 rb experienced needle breakage inside patient.The following information was provided by the initial reporter: material no.309597, batch no.7309904 and 8059526.(2 out of 2).Patient claims that syringe and needle provided in the kit for injection is horrible.Has trouble drawing up and states needles have previously come off syringe and got stuck in his leg.

• Brand Name: SYRINGE 1ML S/T W/NDL 26X5/8 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8564844
• MDR Text Key: 145776638
• Report Number: 1213809-2019-00484
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: 30382903095972
• Combination Product (y/n): N
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309597
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other