MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY; PISTON SYRINGE

Catalog Number 309703

Device Problem Leak/Splash (1354)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

It was reported that one bd luer-lok¿ syringe bulk sterile pharmacy convenience tray syringe each from lots 2153045 and 2090477 leaked past the plunger stopper.The following information was provided by the initial reporter: 'i just wanted to report that my staff found 5 ml syringes that were leaking past the rubber stopper.".

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows:.Medical device lot #: 2153045,.Medical device expiration date: 31-mar-2027, device manufacture date: 20-jun-2022.Medical device lot #: 2090477, medical device expiration date: 31-jan-2027,.Device manufacture date: 14-apr-2022.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 one bd luer-lok¿ syringe bulk sterile pharmacy convenience tray syringe each from lots 2153045 and 2090477 leaked past the plunger stopper.The following information was provided by the initial reporter: 'i just wanted to report that my staff found 5 ml syringes that were leaking past the rubber stopper".

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the 1 photo and 12 samples submitted for evaluation.The reported issue of leakage past stopper was confirmed upon inspection of the photo.However, since the samples were returned with an unknown medication the samples could not be thoroughly analyzed.Only a limited examination could be performed.Bd was not able to determine the root cause of the failure shown in the sample photo with the limited examination.Unused physical samples from the complaint lots are required for a more in-depth evaluation.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch was in compliance with our product specification requirements.

• Brand Name: BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15488806
• MDR Text Key: 306350216
• Report Number: 9610847-2022-00367
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903097036
• UDI-Public: (01)00382903097036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309703
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• 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