MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SP S/SU WHITACRE; ANETHESIA NEEDLE

Catalog Number	409443
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
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 before use of the needle sp s/su whitacre, the product was received damaged due to a perforation in the seal of the packaging.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: a photo was returned for evaluation.Evaluation of the photo was performed through the operators interview.The failure was observed in the photo and is caused by jam in the loading station.After any jam in the loader station the operators are responsible to remove any damaged units prior to re-start the machine.Based on this evaluation, the most probable cause of the reported failure was an incomplete removal of damaged units by the operators after machine loader jam.Manufacturing records review: a review of the device history record was completed for lot 7053617.Product was manufactured from 23feb2017 to 24feb2017 on insert molded machine.In process inspections are performed at shift start up and every 4 hours including cannula/stylet visual characteristics, dimensional and functional.Final inspection by quality were performed on 24feb2017.According to lot quality records, all in-process and final inspections were found in compliance with requirements.Lot was packed on multivac machine during 27feb2017 lot 705317.Packaging inspections were performed on 27feb2017 at shift start up and every hour for visual characteristics such and functional test including blister holes and correct position of components inside blisters.All performed inspection passed with satisfactory results, no machine interventions or events reported.Lot was released for shipping on 28feb2017; expiration date 28feb2022.A total of 33,850 units were released from sterilization on 30mar2017.Preventive maintenance were conducted as per schedule.Review of instrument calibrations listed in the inspection forms and dhrs was conducted and they were calibrated within their calibration due dates.Multivac machine process failure mode and effect analysis (pfmea), was reviewed and the failure observed in the complaint picture is related to jam in the loading station.After any jam in the loader station the operators are responsible to remove any damaged units prior to re-start the machine.The machine sensors detects presence of unit in the blisters.As per pfmea, the current controls in placed are the shift start up verifications, in process inspection and final quality audit.This is the 1st related complaint for package poor perforation/seal on the provided lot number (7053617).Conclusion: bd was able to confirm the customer¿s indicated failure mode with the picture provided in the complaint.

• Brand Name: NEEDLE SP S/SU WHITACRE
• Common Device Name: ANETHESIA NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7148623
• Report Number: 2618282-2017-00042
• Device Sequence Number: 1903297
• Product Code: CAZ
• UDI-Device Identifier: 00382904094430
• UDI-Public: 00382904094430
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 02/28/2022
• Device Catalogue Number: 409443
• Device Lot Number: 7053617
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/06/2018
• 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