MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE 18 G X 1 IN.; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number	305181
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd¿ blunt fill needle 18 g x 1 in.Had damaged packaging, potentially impacting product sterility.The following information was provided by the initial reporter: "pieces of plastic were found to be torn from the plastic surface in the needle heads.The incidence of the pieces is quite high (estimated at about 15% of the needles).".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 12-may-2022.H6: investigation: it was reported pieces of plastic were found to be torn from the plastic surface in the needle heads.To aid in the investigation, four samples in a plastic bag with the plastic shield, but with no packaging blisters, were received for evaluation by our quality team.A visual inspection was performed with a 10x magnifier lens and no defects or imperfections were observed.A device history record review was completed for provided material number 305181, lot number 1144451.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.
Event or Problem Description
It was reported bd¿ blunt fill needle 18 g x 1 in.Had damaged packaging, potentially impacting product sterility.The following information was provided by the initial reporter: ".Pieces of plastic were found to be torn from the plastic surface in the needle heads.The incidence of the pieces is quite high (estimated at about 15% of the needles).".

• Brand Name: BD¿ BLUNT FILL NEEDLE 18 G X 1 IN.
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• 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 ; 8015296192
• MDR Report Key: 14207816
• Report Number: 1911916-2022-00218
• Device Sequence Number: 14582682
• Product Code: GAA
• UDI-Device Identifier: 30382903051817
• UDI-Public: 30382903051817
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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: Other
• Device Expiration Date: 07/31/2026
• Device Model Number: 305181
• Device Catalogue Number: 305181
• Device Lot Number: 1144451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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