MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 22 G X 1 1/2 IN. BD INTEGRA¿ NEEDLE; SAFETY ENGINEERED HYPODERMIC NEEDLE

Catalog Number	305313
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).It is unknown if a sample will be returned 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 the connection of the 22 g x 1 1/2 in.Bd integra" needle and the syringe were loose causing the fluid to leak.There was no report of exposure, injury or medical interventions.
Additional Manufacturer Narrative
Investigation results: five representative needles with connection (hubs) were returned to the (b)(4) plant for evaluation.The packages were not opened.Product is within specification.Representatives were leak tested and there was no leakage between connection of the syringe and needle.Dhr was performed: 305313/5212683 convert to 8000599/5212549 was produced on 11/12/15 with zero defects found.Conclusion: root cause could not be identified using representative samples.Without actual needle and actual syringe used we were unable to confirm complaint.No additional corrective action is required at this time.

• Brand Name: 22 G X 1 1/2 IN. BD INTEGRA¿ NEEDLE
• Common Device Name: SAFETY ENGINEERED HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 6956157
• Report Number: 1911916-2017-00270
• Device Sequence Number: 567024
• Product Code: MEG
• UDI-Device Identifier: 30382903053132
• UDI-Public: 30382903053132
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 10/31/2020
• Device Catalogue Number: 305313
• Device Lot Number: 5212683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 02/05/2018
• 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