MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD 3ML PRE-FILLED SYRINGE; VASCULAR ACCESS FLUSH

Catalog Number UNKNOWN

Device Problem Defective Component (2292)

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

Event Date 05/29/2023

Event Type  malfunction  

Event Description

It was reported that prior to use with unspecified bd 3ml pre-filled syringe the syringe barrel was discovered to be damaged.The following information was provided by the initial reporter, translated from chinese to english: when prefilling the patient, after opening the package of the flush, it was found that the rear section of the syringe of the flush was damaged and cracked, and could not be used normally; replace other flush.

Manufacturer Narrative

D.4.Medical device expiration date: unknown e.1.Initial reporter phone #: (b)(6).H.4.Device manufacture date: unknown h.6.Investigation summary: as no physical sample, picture sample, material or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: UNSPECIFIED BD 3ML PRE-FILLED SYRINGE
• Type of Device: VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17276145
• MDR Text Key: 318648903
• Report Number: 2243072-2023-01179
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• 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
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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