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

Device Problem Packaging Problem (3007)

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

Event Date 03/29/2022

Event Type  malfunction  

Event 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).".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

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 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.
• Type of Device: 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
• MDR Text Key: 290068878
• Report Number: 1911916-2022-00218
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903051817
• UDI-Public: 30382903051817
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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