MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC NEEDLE

Catalog Number	305176
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd precision glide¿ needle the physician noticed plastic debris when using needles for injections on patients.There was no further report of injury or medical intervention.
Additional Manufacturer Narrative
Results: bd received (51) fifty-one samples in a sealed carton to the columbus plant for evaluation.However, the samples returned were for material (b)(4), batch 7086862 (25 x 1 1/2¿), and not for the material / batch referenced in the complaint therefore failure mode could not be verified.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.All inspections performed during assembly and packaging were acceptable, and all product met the required specification.All cleaning was performed according to the documented procedure.No quality notifications were written for this batch, nor for the associated assembly batch.Bd was unable to confirm or duplicate the customer's indicated failure mode for foreign matter.Conclusion: unable to determine the root cause since the defect was not confirmed.No capa will be initiated at this time.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7155133
• Report Number: 1911916-2017-00380
• Device Sequence Number: 111805
• Product Code: FMI
• UDI-Device Identifier: 30382903051763
• UDI-Public: 30382903051763
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 305176
• Device Lot Number: 6208860
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other