MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 22GA 5IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Model Number 405148

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.510k number: preamendment.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that needle spinal s/su 22ga 5in quincke contained foreign matter.The following information was provided by the initial reporter: "it was reported that hair was found in sealed package of the spinal needle.Event description: hello, i need to report a complaint on a product involving a hair found in packaging of a spinal needle.The issue was reported yesterday by: safety officer (b)(6).The complaint is a hair was found in the packaging spinal needle.Questions/inquiries: how many affected items involved? what is the date of the event? do you have sample(s) available that can be sent back for evaluation? if so, please await follow-up email which will contain instructions and pre-paid return shipping label to return samples for investigation.

Event Description

It was reported that needle spinal s/su 22ga 5in quincke contained foreign matter.The following information was provided by the initial reporter: "it was reported that hair was found in sealed package of the spinal needle.Event description: hello, i need to report a complaint on a product involving a hair found in packaging of a spinal needle.The issue was reported yesterday by: (b)(6).The complaint is a hair was found in the packaging spinal needle, see attached photos.Questions/inquiries: how many affected items involved? what is the date of the event? do you have sample(s) available that can be sent back for evaluation? if so, please await follow-up email which will contain instructions and pre-paid return shipping label to return samples for investigation.

Manufacturer Narrative

H6: investigation summary: one photo was received by our quality team for evaluation.Upon visual inspection, it was observed that foreign matter was present inside the blister packaging.It appeared to be a piece of hair; therefore, the incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.New actions have been implemented to mitigate new events of foreign matter.Awareness of the complaint was provided to supervisors and team leaders.Internal and customer incidents will continue to be monitored to determine if any future action will need to be taken in monthly data quality trends.

• Brand Name: NEEDLE SPINAL S/SU 22GA 5IN QUINCKE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 10687882
• MDR Text Key: 213505650
• Report Number: 2618282-2020-00081
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051489
• UDI-Public: 30382904051489
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 405148
• Device Catalogue Number: 405148
• Device Lot Number: 0069476
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other