MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 20ML E/T PRECISE; PISTON SYRINGE

Catalog Number 300142

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

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 when using the bd syringe 20ml e/t precise, the device experienced leakage.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: are faulty leaking at the base of the syringe.As the rubber doesn't fit correctly.Please inform the company / supplier.Have removed a whole box of the shelf 10 were ¿ tried all the same.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/19/2021.H.6.Investigation: ten representative samples from batch 1049932 were received by our quality team for evaluation.From the samples, no defective or damaged stopper or stopper mis-assembly were observed.A device history record review found no non-conformances associated with this issue during production of the nonreported batch.At the syringe assembly machine, there is sensor installed to detect and reject parts with stopper mis-assembly which is tested daily.The assembly process has a mechanism control to check the stopper leakage.Based on the investigation and dhr reviewed, there is no sensor or vision system abnormality during the production of the received batch, therefore the root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported when using the bd syringe 20ml e/t precise, the device experienced leakage.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: are faulty leaking at the base of the syringe.As the rubber doesn¿t fit correctly.Please inform the company / supplier.Have removed a whole box of the shelf 10 were ¿ tried all the same.

• Brand Name: BD SYRINGE 20ML E/T PRECISE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12425431
• MDR Text Key: 271337609
• Report Number: 8041187-2021-00800
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300142
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1