MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE; SYRINGE WITH NEEDLE

Catalog Number	305310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on 10/11/2017 via medwatch #5072679.A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that after use, a bd integra¿ syringe with retracting needle did not retract completely which resulted in a patient receiving a superficial scratch on her thigh when the syringe was being pulled away.The tip of the needle was still outside the hub of the syringe.There was no report of exposure to mucous membranes, injury or medical interventions.
Additional Manufacturer Narrative
Investigation results: no photos or samples were received in the (b)(4) plant for evaluation therefore failure mode could not be verified and root cause could not be determined.A device history record review found no non-conformance's associated with this issue during production of this batch.Capa not necessary.

• Brand Name: BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7070416
• Report Number: 1911916-2017-00360
• Device Sequence Number: 1132363
• Product Code: FMF
• UDI-Device Identifier: 30382903053101
• UDI-Public: 30382903053101
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 305310
• Device Lot Number: 6048798
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 03/01/2018
• 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