MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ LUER-SLIP SYRINGE; PISTON SYRINGE

Catalog Number 302143

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that a luer-lock syringe was found in the pack of bd¿ luer-slip syringes.The following information was provided by the initial reporter: "hospital staff noticed a single l/l syringe in a packet of luer slip syringes with a broken hypodermic needle attached.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: d4: medical device lot #: 2298646.D4: medical device expiration date: 31-oct-2027.H4: device manufacture date: 25-oct-2022.H6: investigation summary our quality engineer inspected the 1 photo and 5 samples submitted for evaluation.The reported issues of mixed products / lots were confirmed upon inspection of the samples.Analysis of the samples showed that showed that there were mixed products within the packaging.Bd determined that the cause of the failure was related to our manufacturing process and production technician failures.Production records were reviewed, and this batch meets our manufacturing specification requirements.

Event Description

It was reported that a luer-lock syringe was found in the pack of bd¿ luer-slip syringes.The following information was provided by the initial reporter: "hospital staff noticed a single l/l syringe in a packet of luer slip syringes with a broken hypodermic needle attached".

• Brand Name: BD¿ LUER-SLIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16968798
• MDR Text Key: 315860969
• Report Number: 8041187-2023-00225
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302143
• Device Lot Number: 2298646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• 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