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

Catalog Number	305311
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.H 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 that before use of the bd integra¿ syringe, retracting needle "the protective cap has become dislodged from the needle inside the package and the needle is protruding through the outside plastic wrapper".There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that before use of the bd integra syringe, retracting needle "the protective cap has become dislodged from the needle inside the package and the needle is protruding through the outside plastic wrapper".There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Dhr: no issues related to these complaints were recorded while producing these batches.No qns were issued as well.

• Brand Name: BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7813845
• Report Number: 1911916-2018-00473
• Device Sequence Number: 19129758
• Product Code: MEG
• UDI-Device Identifier: 30382903053118
• UDI-Public: 30382903053118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• 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): 09/27/2018

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: 10/31/2021
• Device Catalogue Number: 305311
• Device Lot Number: 6299679
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/06/2018
• 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