MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ LUER-LOCK SYRINGE TIP CAP TRAY; LIQUID MEDICATION DISPENSER

Catalog Number 308341

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2213610 d.4.Medical device expiration date: 31-jul-2027 h.4.Device manufacture date: 12-sep-2022 d.4.Medical device lot #: 2234926 d.4.Medical device expiration date: 31-aug-2027 h.4.Device manufacture date: 01-nov-2022 h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1026 bd¿ tip cap tray luer-lock syringes each from lots 2213610 and 2234926 leaked.The following information was provided by the initial reporter: "customer complained about syringe leakage.Tip caps are not securely tight on 1ml bd syringe causing leakage.Patient injury?: no.Are you able to provide the number of defective syringes that was found during the incident?: we do not know the defect.Where the leakage is coming from.Was this incident noted before use or during/after use?: during use".

Event Description

It was reported that 1026 bd¿ tip cap tray luer-lock syringes each from lots 2213610 and 2234926 leaked.The following information was provided by the initial reporter: "customer complained about syringe leakage.Tip caps are not securely tight on 1ml bd syringe causing leakage.Patient injury? (y/n) no.2.Are you able to provide the number of defective syringes that was found during the incident? we do not know the defect.Where the leakage is coming from.3.Was this incident noted before use or during/after use? during use".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 02-jun-2023 h6: investigation summary forty samples and photo were received our quality team for investigation.Upon visual evaluation, no damage or molding defect observed.Further testing was conducted, results for diameter measurements of the tip caps are within specification.A device history review was performed for lot 2213610, 2234926 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Final products for tip caps, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the quality team's investigation, and manufacturing record established that all production and quality processes were carried out normally, we are not able to identify a root cause related to our manufacturing process at this time.

• Brand Name: BD¿ LUER-LOCK SYRINGE TIP CAP TRAY
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17035635
• MDR Text Key: 316295650
• Report Number: 2618282-2023-00040
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 00382903083411
• UDI-Public: 00382903083411
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 308341
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BD¿ LUER-LOCK SYRINGE TIP CAP TRAY