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	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter: address unavailable.Bd corporate address used.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.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿material no.: 309572, batch no.: 8300796.It was reported the contents leaked out of the barrel past the stopper.Per email: (lot 8300796 ¿ five instances between the two hospitals ¿ they didn¿t break it down further).Per (b)(4).Petnet (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 wasescaping the barrel through the plunger seal.".
Event or Problem Description
It was reported that bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle leaked.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿material no.: 309572 batch no.: 8300796.It was reported the contents leaked out of the barrel past the stopper.Per email: (lot 8300796 five instances between the two hospitals they didn¿t break it down further) per 1213809-2019-00387 - 1 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
H.6.Investigation: three photos were received and evaluated.Two photos displayed 100-count labels from batch #8300798 and batch #8300796 (p/n 309752).One photo displayed a syringe of unknown volume inside a metal device with clear liquid droplets on the plunger rod.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.Root cause not defined since defects were not confirmed in the photos received.

• 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: 8464106
• Report Number: 1213809-2019-00387
• Device Sequence Number: 1634381
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 05/06/2019

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: 09/30/2023
• Device Catalogue Number: 309572
• Device Lot Number: 8300796
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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