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

Catalog Number 300841

Device Problems Volume Accuracy Problem (1675); Missing Information (4053)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 there were no scale markings on the bd¿ slip tip syringe with precisionglide¿ needle.The following information was provided by the initial reporter, translated from chinese: "when using a 1 ml syringe, there was no scale on the syringe needle and it was unusable.No harm was caused to the patient.".

Event Description

When using a 1 ml syringe, there was no scale on the syringe needle and it was unusable.No harm was caused to the patient.

Manufacturer Narrative

No photo/sample were received for further investigation.Root cause could not be determined.Review of the dhr showed that no abnormality was observed during production run of this reported batch.Current control there is a daily qa routine volumetric test per mfg-006/n in place to determine precision of scale on assembled syringes.The complaint will be re-opened and re-investigated when sample is received.

• Brand Name: BD¿ SLIP TIP SYRINGE WITH 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17926356
• MDR Text Key: 325845134
• Report Number: 8041187-2023-00532
• Device Sequence Number: 1
• Product Code: FMF
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300841
• Device Lot Number: 1356115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• 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