MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number 305180

Device Problem Contamination (1120)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was reported that an unspecified number of bd¿ blunt fill needles caused coring to occur in the medication vials during use.The following information was provided by the initial reporter: "they have had a few instances of coring with the blunt needles.After doing some more investigation, it sounds like it¿s an issue with only one nurse.However, one of the pharmacists observed her technique and said it was correct.One of the nursing supervisors and i purposefully tried to core several different vials without success.".

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that an unspecified number of bd¿ blunt fill needles caused coring to occur in the medication vials during use.The following information was provided by the initial reporter: "they have had a few instances of coring with the blunt needles.After doing some more investigation, it sounds like it¿s an issue with only one nurse.However, one of the pharmacists observed her technique and said it was correct.One of the nursing supervisors and i purposefully tried to core several different vials without success.".

Manufacturer Narrative

It was reported there was a few instances of coring with blunt fill needles.As no photo or sample was returned, a thorough sample investigation could not be completed.Communication noted that this event was due to user error and retraining would be performed.As the lot provided is 'unknown,' a device history record review could not be completed.H3 other text : see h10.

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 16695300
• MDR Text Key: 313566294
• Report Number: 1911916-2023-00210
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: 00382903051809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

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: Health Professional
• Device Catalogue Number: 305180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/04/2023
• 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