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

Model Number 309623

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.Dhr review: release date: 9/10/2019.Released quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 9234142 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: since no samples displaying the reported condition were received a potential root cause could not be defined.Rationale: since no samples displaying the reported condition were received corrective actions are not necessary.

Event Description

It was reported that while placing the cap on the bd¿ tuberculin syringe with bd precisionglide¿ detachable needle during use, the needle pierced through it and stuck the user's left middle finger.A physician looked over the needle stick injury, and blood work was advised.The following information was provided by the initial reporter: "giving a patient a flu vaccine and after she finished she was placing the cap back on the needle.The needle was inside the cap but when she added pressure to the cap, the needle came through the side of the cap and punctured her on the left middle finger." "had physician she works for look at her finger." "workman's comp has advised she have bloodwork done to test for hep b c and hiv".

• Brand Name: BD TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10743067
• MDR Text Key: 213390886
• Report Number: 1213809-2020-00747
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096238
• UDI-Public: 30382903096238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 309623
• Device Catalogue Number: 309623
• Device Lot Number: 9234142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention