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

Catalog Number	305904
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
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 safetyglide syringe with detachable needle plungers bend easily.This was discovered during use.The following information was provided by the initial reporter: material no.: 305904; batch no.: 8330741.It was reported that the plungers bend easily with this lot.Name was spelled incorrectly.Made correction and its a facility reporting issue.Medical professional reported plunger are too "weak".With this lot.Stated, bending easy when tried filling it with "lidocaine".Has 3 boxes but only using 1 box.Wants all 3 boxes replaced, not comfortable continuing to use this lot.
Additional Manufacturer Narrative
H.6.Investigation: three 3ml safetyglide combo packs from batch from 8330741 (p/n 305904) were received and evaluated.No visual defects were observed.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.The root cause cannot be attributed to the manufacturing process at this time.The plunger rod is made of polypropylene ¿ a type of plastic, which may bend if subjected to sufficient force.It is unclear what type of process was used to fill the syringes.The product is manufactured in accordance with (b)(4) and meets those requirements.
Event or Problem Description
It was reported that bd safetyglide¿ syringe with detachable needle plungers bend easily.This was discovered during use.The following information was provided by the initial reporter: material no.: 305904 batch no.: 8330741.It was reported that the plungers bend easily with this lot.Per verbatim: name was spelled incorrectly.Made correction and its a facility reporting issue.Medical professional reported plunger are too "weak".With this lot.Stated, bending easy when tried filling it with "lidocaine".Has 3 boxes but only using 1 box.Wants all 3 boxes replaced, not comfortable continuing to use this lot.

• Brand Name: BD SAFETYGLIDE SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9161633
• Report Number: 1213809-2019-01005
• Device Sequence Number: 13986200
• Product Code: FMF
• UDI-Device Identifier: 30382903059042
• UDI-Public: 30382903059042
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 12/04/2019

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: 11/30/2023
• Device Catalogue Number: 305904
• Device Lot Number: 8330741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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