MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA NEEDLE; PISTON SYRINGE

Catalog Number	305311
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 6139911, medical device expiration date: 2021-05-31, device manufacture date: 2016-08-25.Medical device lot #: 6299679, medical device expiration date: 2021-10-31, device manufacture date: 2016-12-02.Device evaluated by mfr: 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 the bd integra¿ needle wouldn't retract during use after removing it from the patient.Lot #'s 6139911 and 6299679 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.The following information was provided by the initial reporter: "needle is not retracting after withdrawing from the patient".
Event or Problem Description
It was reported that the bd integra¿ needle wouldn't retract during use after removing it from the patient.Lot #'s 6139911 and 6299679 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.The following information was provided by the initial reporter: "needle is not retracting after withdrawing from the patient".
Additional Manufacturer Narrative
Investigation: no samples or photos were provided by the customer for investigation.A device history record (dhr) review was performed on the batches associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed nor could this symptom be correlated with a potential cause linked to the bd process.

• Brand Name: BD INTEGRA NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8716468
• Report Number: 1911916-2019-00607
• Device Sequence Number: 2022380
• Product Code: MEG
• UDI-Device Identifier: 30382903053118
• UDI-Public: 30382903053118
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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 Catalogue Number: 305311
• Device Lot Number: SEE SECTION H.10.
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/01/2019
• 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