MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ BLUNT CANNULA TRANSFER DEVICE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number UNKNOWN

Device Problem Contamination (1120)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.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.H3 other text : see h10.

Event Description

It was reported that the unspecified bd¿ blunt cannula transfer device cored a piece of the vial's stopper into the syringe while withdrawing methylprenisolone.The following information was provided by the initial reporter, translated from french: "core sampling.While withdrawing methylprenisolone 40mg (mylan) using a bd blunt needle (18g*40mm), the nurse saw a core of the septum of the vial in the syringe.Information was collected from one of her colleagues who saw the piece of septum in the syringe, but did not witness the preparation and drawing of the solution.It appears that the technique of percussion of the septum was done in accordance, at 90°.The chemotherapy department informed us yesterday of a problem of coring with the use of a bd blunt needle (18g*40mm), which is currently used instead of the so-called "pumping" needles (the "pink" ones in 18g * 40 mm, ref 304622) in breakage.We had been assured that they are precisely "anti-coring".

• Brand Name: UNSPECIFIED BD¿ BLUNT CANNULA TRANSFER DEVICE
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16932436
• MDR Text Key: 315411175
• Report Number: 2243072-2023-00796
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• 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