MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 18X1IN BLUNT FILL; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	305181
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the needle 18x1in blunt fill experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: the needles do not adapt well to bd plastipak syringes.The pumping machines do not adapt when placed on the syringe.The needles do not fit well on the bd plastipak syringes and become unsuitable when placed on the syringe.This has happened on several occasions.The device has been kept.
Event or Problem Description
It was reported that the needle 18x1in blunt fill experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: the needles do not adapt well to bd plastipak syringes.The pumping machines do not adapt when placed on the syringe.The needles do not fit well on the bd plastipak syringes and become unsuitable when placed on the syringe.This has happened on several occasions.The device has been kept.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/22/2021.H.6.Investigation: a device history record review was completed for provided material number 305181 and lot number 0115930.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, sixty three physical samples were received for evaluation by our quality team.Sixty one samples came in sealed packaging blisters and two came in opened packaging blisters.With the needle assemblies came a 10ml syringe with a green stopper.The syringe is a bd product, but not produced by the columbus site.Fifteen random samples were visually inspected and no defects or imperfections were observed.A leak test was performed on these samples and no leakage occurred.Based on the investigation results, the random samples investigated did not show the symptom reported by the customer and an exact cause for this incident could not be identified.H3 other text : see h.10.

• Brand Name: NEEDLE 18X1IN BLUNT FILL
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11181497
• Report Number: 1911916-2021-00034
• Device Sequence Number: 2385217
• Product Code: GAA
• UDI-Device Identifier: 00382903051816
• UDI-Public: 00382903051816
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 05/31/2025
• Device Catalogue Number: 305181
• Device Lot Number: 0115930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1