MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP; PISTON SYRINGE

Catalog Number 302995

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 3 bd syringe luer-lok¿ tip barrels were found cracked, with one incident resulting in the patient's blood squirting out and into the caregiver's eye while administering fluid.The patient reportedly tested (b)(6) for (b)(6), but no medical intervention or further details regarding the event have been provided by the customer.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "customer experienced 3 instances of the bd syringes being cracked along the cylinder.We had an incident where the caregiver administering fluid to the patient, had the syringe crack, which caused the patient¿s blood to squirt back on to the care giver, compromising sterility and getting the patient¿s blood into the caregivers eye.The patient tested (b)(6) for (b)(6).".

Manufacturer Narrative

H.6.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 could not be performed as lot number was unknown.H3 other text : see h.10.

Event Description

It was reported that 3 bd syringe luer-lok¿ tip barrels were found cracked, with one incident resulting in the patient's blood squirting out and into the caregiver's eye while administering fluid.The patient reportedly tested positive for hepatitis b and hiv, but no medical intervention or further details regarding the event have been provided by the customer.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "customer experienced 3 instances of the bd syringes being cracked along the cylinder.We had an incident where the caregiver administering fluid to the patient, had the syringe crack, which caused the patient¿s blood to squirt back on to the care giver, compromising sterility and getting the patient¿s blood into the caregivers eye.The patient tested positive for hep b and hiv.".

• Brand Name: BD SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8678705
• MDR Text Key: 147345187
• Report Number: 1213809-2019-00598
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903029953
• UDI-Public: 30382903029953
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 302995
• Device Lot Number: 9064509
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other