MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK; PISTON SYRINGE

Catalog Number	309701
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 25 bd 1 ml syringe luer slip tip convenience paks experienced molding defects short shots on barrel.The following information was provided by the initial reporter: material no: 309701, batch no: 0092223.I'm reaching out in regards to what appears to be a molding issue with our 1ml slip tip syringe's.This particular issue is found in the 25 count trays that we order.The defect appears to be a small indentation and is about 0.5 cm in length, it is the same size and shape on every affected syringe that we encounter leading us to believe it could be an error with the molding.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided final lot number 0092223 and all applicable sub-assembly lot numbers.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, the barrel cavity of the syringe was observed damaged.The damages appeared to be elongated and indented.It has been determined that the damaged barrels most likely resulted during the bd assembly process; however, and exact point of error has not been identified.See h.10.
Event or Problem Description
It was reported that 25 bd 1 ml syringe luer slip tip convenience paks experienced molding defects -short shots on barrel.The following information was provided by the initial reporter: material no: 309701 batch no: 0092223 i'm reaching out in regards to what appears to be a molding issue with our 1ml slip tip syringe's.This particular issue is found in the 25 count trays that we order.The defect appears to be a small indentation and is about 0.5 cm in length, it is the same size and shape on every affected syringe that we encounter leading us to believe it could be an error with the molding.

• Brand Name: BD 1 ML SYRINGE LUER SLIP TIP CONVENIENCE PAK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10962197
• Report Number: 9610847-2020-00397
• Device Sequence Number: 583798
• Product Code: FMF
• UDI-Device Identifier: 00382903097012
• UDI-Public: 00382903097012
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 309701
• Device Lot Number: 0092223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1