MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number 309572

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8300798, medical device expiration date: 2023-10-31, device manufacture date: 2018-10-27.Medical device lot #: 8300796, medical device expiration date: 2023-09-30, device manufacture date: 2018-10-27.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 a bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle had leakage.The following was reported, "was reported the plunger pulled out of the syringe barrel too easily and the contents leaked out.It was also reported the needle caps were noticeably loose and would not click when closing.Customer complaint received from two hospitals regarding a loose plunger which caused leaking of contents.Specifically, one instance with lot# 8300798 (expiry 10/31/2023) where the plunger pulled out of the cylinder too easily and the syringe contents were lost.There were also multiple instances with this lot where the needle caps were noticeably looser than prior lots (the caps stayed attached, but no noticeable click when closing) five instances with lot# 8300796 (expiry 09/30/2023) where the liquid was escaping the barrel through the plunger seal.".

Event Description

It was reported that a bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle had leakage.The following was reported, " was reported the plunger pulled out of the syringe barrel too easily and the contents leaked out.It was also reported the needle caps were noticeably loose and would not click when closing.Customer complaint received from two hospitals regarding a loose plunger which caused leaking of contents.Specifically, one instance with lot# 8300798 (expiry 10/31/2023) where the plunger pulled out of the cylinder too easily and the syringe contents were lost.There were also multiple instances with this lot where the needle caps were noticeably looser than prior lots (the caps stayed attached, but no noticeable click when closing) five instances with lot# 8300796 (expiry 09/30/2023) where the liquid was escaping the barrel through the plunger seal.

Manufacturer Narrative

The following field was updated due to corrected information: b.5.Describe event or problem:it was reported that a bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle had leakage.The following was reported, " was reported the plunger pulled out of the syringe barrel too easily and the contents leaked out.It was also reported the needle caps were noticeably loose and would not click when closing.Customer complaint received from two hospitals regarding a loose plunger which caused leaking of contents.Specifically, one instance with lot# 8300798 (expiry 10/31/2023) where the plunger pulled out of the cylinder too easily and the syringe contents were lost.There were also multiple instances with this lot where the needle caps were noticeably looser than prior lots (the caps stayed attached, but no noticeable click when closing) five instances with lot# 8300796 (expiry 09/30/2023) where the liquid was escaping the barrel through the plunger seal.H.6.Investigation: a total of 21 samples were received: 11 sealed packaged syringes from batch #8300796 and 10 sealed packaged syringes from batch #8300798 (p/n 309572).They were visually evaluated.The syringes were found to have barrel retaining ring present as designed.No visual defects were observed.The samples from batch 8300796 were tested for leakage past stopper per procedure.All syringes passed with no leakage observed.The samples from batch 8300798 were evaluated for shield removal force.All samples passed.Even though some of the samples were found to be on the low end of the range (less force required to remove) ¿ all were within the acceptable range per product specification.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8426107
• MDR Text Key: 142631172
• Report Number: 1213809-2019-00344
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309572
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other