MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SLIP-TIP SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE; PISTON SYRINGE

Catalog Number 301942

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/08/2022

Event Type  malfunction  

Event Description

It was reported that the seal of the bd¿ syringe plunger stopper was loose.The following information was provided by the initial reporter, translated from chinese: "when it want to use the product, it is found that the seal is not tight, and it should be replaced".

Manufacturer Narrative

Initial reporter e-mail: unknown.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 seal of the bd¿ syringe plunger stopper was loose.The following information was provided by the initial reporter, translated from chinese: "when it want to use the product, it is found that the seal is not tight, and it should be replaced".

Manufacturer Narrative

H6: investigation summary: a device history record review was completed for provided material number 301942 and lot number 2107217.All of the production and inspections records have established that all production and quality processes were carried out normally with no quality notifications or non-conformances.All inspections performed for packaging integrity for this lot were also within specifications.Based on the limited feedback provided, it is not possible to identify the exact event that occurred.It is unknown if the seal mentioned is in reference to the seal of the syringe (plunger and barrel components) or the unit packaging seal.As samples were unavailable for return, twenty retained samples were obtained for review; however, no signs of defect could be found in the retained samples.Based on the investigation results, no defects could be identified and therefore, no cause could be determined for the reported incident.

• Brand Name: BD SLIP-TIP SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15546393
• MDR Text Key: 301591121
• Report Number: 3002682307-2022-00260
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903019427
• UDI-Public: (01)00382903019427
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/25/2022

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: 301942
• Device Lot Number: 2107217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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