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

Catalog Number 302104

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the stoppers in 2 bd luer-slip syringes with the bd precisionglide¿ needle were loose and allowed liquid to leak past them.The following information was provided by the initial reporter: "the stopper is too loose to stop the liquid.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-sep-2022.H6: investigation summary : two actual samples were received by our quality team for evaluation.From the returned samples, no leakage past the stopper was observed.The samples were subjected to leakage testing and passed the inspection.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.At the assembly process, there is a mechanism control to check the stopper leakage.Based on the quality team's investigation, the root cause of this incident cannot be determined.

Event Description

It was reported that the stoppers in 2 bd luer-slip syringes with the bd precisionglide¿ needle were loose and allowed liquid to leak past them.The following information was provided by the initial reporter: "the stopper is too loose to stop the liquid".

• Brand Name: BD LUER-SLIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE
• 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 ; 8015296192
• MDR Report Key: 15490810
• MDR Text Key: 306337948
• Report Number: 8041187-2022-00561
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903021048
• UDI-Public: (01)00382903021048
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 10/14/2022

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
• Device Operator: Other
• Device Catalogue Number: 302104
• Device Lot Number: 1322913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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