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

Catalog Number	309701
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 1ml st bulk convenience pak stopper was defective/damaged.The following information was provided by the initial reporter translated from french to english: "i'm writing to let you know about a problem i've had this past month with the syringes in the tip1cc slip bulks.The liquid passes by the black rubber and flows down the piston.So, contaminated product.Several syringes with the plastic striped." je vous écris pour vous faire part d'un problème rencontré ce dernier mois avec les seringues des bulks de slip tip 1cc.Le liquide passe à côté du cahoutchou noir et coule au niveau du piston.Donc, produit contaminé.Plusieurs seringues avec le plastique rayé.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed by our quality engineer team for provided material number 309701 and lot number 3212533.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SYRINGE 1ML ST BULK 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18698250
• Report Number: 9610847-2024-00028
• Device Sequence Number: 7271567
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: (01)30382903097013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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 Catalogue Number: 309701
• Device Lot Number: 3212533
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown