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

Catalog Number	309572
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle leaked from the barrel through the plunger seal.This occurred on 5 separate occasions.No serious injury or medial intervention was reported.Verbatim: "material no.: 309572 batch no.: 8300796.It was reported the liquid escaped the barrel through the plunger seal.Per (b)(6), (b)(6) 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.Please see photos on the following page.".
Additional Manufacturer Narrative
The following fields have been updated with corrections: d.4.Medical device expiration date: 2023-10-31.
Event or Problem Description
It was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle leaked from the barrel through the plunger seal.This occurred on 5 separate occasions.No serious injury or medial intervention was reported.Verbatim: "material no.: 309572 batch no.: 8300796.It was reported the liquid escaped the barrel through the plunger seal per (b)(4).Petnet detroit & houston.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.
Additional Manufacturer Narrative
The following field was updated due to corrected information: b.5.Describe event or problem: it was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle leaked from the barrel through the plunger seal.This occurred on 5 separate occasions.No serious injury or medial intervention was reported.Verbatim: "material no.: 309572 batch no.: 8300796.It was reported the liquid escaped the barrel through the plunger seal per (b)(4).Petnet detroit & houston.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.Investigation: 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.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.
Event or Problem Description
It was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle leaked from the barrel through the plunger seal.This occurred on 5 separate occasions.No serious injury or medial intervention was reported.Verbatim: "material no.: 309572 batch no.: 8300796.It was reported the liquid escaped the barrel through the plunger seal per (b)(4).Petnet detroit & houston.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.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8416997
• Report Number: 1213809-2019-00325
• Device Sequence Number: 16593097
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2019

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: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 309572
• Device Lot Number: 8300796
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019; 02/26/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 03/13/2019; 05/10/2019
• 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: Other