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

Catalog Number	305181
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ blunt fill needle with syringe caused visible coring in 7 daptomycin vials.The following information was provided by the initial reporter: "today we did a small trial using the bd blunt fill needles (18g x 1 inch ref (b)(4); lot 3086627 exp 5/31/2028).I reviewed the appropriate technique with our pharmacy technician.She then reconstituted 20 vials of daptomycin using them.Of the 20 vials we saw visible cores in 5 of them.None were sent out to patients.We also withdrew doses from several other daptomycin vials that had been reconstituted the previous day and were stored in the fridge.None of the vials contained a visible core.However when we used the blunt fill needles to withdraw doses we had visible cores in 7 of the final dose syringes.We then filtered them so we could use the medication.At this point the blunt fill needles don�t seem to be working to prevent coring of these vials.".
Additional 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.
Additional Manufacturer Narrative
H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 305181 and lot number 3086627.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.H3 other text : see h10.
Event or Problem Description
It was reported that the bd¿ blunt fill needle with syringe caused visible coring in 7 daptomycin vials.The following information was provided by the initial reporter: "today we did a small trial using the bd blunt fill needles (18g x 1 inch ref (b)(4); lot 3086627 exp 5/31/28).I reviewed the appropriate technique with our pharmacy technician.She then reconstituted 20 vials of daptomycin using them.Of the 20 vials we saw visible cores in 5 of them.None were sent out to patients.We also withdrew doses from several other daptomycin vials that had been reconstituted the previous day and were stored in the fridge.None of the vials contained a visible core.However when we used the blunt fill needles to withdraw doses we had visible cores in 7 of the final dose syringes.We then filtered them so we could use the medication.At this point the blunt fill needles don�t seem to be working to prevent coring of these vials.".

• Brand Name: BD¿ BLUNT FILL NEEDLE WITH SYRINGE
• Common Device Name: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17799926
• Report Number: 1911916-2023-00683
• Device Sequence Number: 15266385
• Product Code: GAA
• UDI-Device Identifier: 00382903051816
• UDI-Public: 00382903051816
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 305181
• Device Lot Number: 3086627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown