MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 22GA 3IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Model Number 405171

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: preamendment a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the needle spinal s/su 22ga 3in quincke experienced incorrect label information and a mix of product types in a pack.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.405171, batch no.9290118.Wrong needles inside the box.Received the needles 405160, lot # 8080923 in a box marked 405171.Qty: 1 box.

Event Description

It was reported that the needle spinal s/su 22ga 3in quincke experienced incorrect label information and a mix of product types in a pack.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.405171; batch no.9290118 wrong needles inside the box.Received the needles 405160, lot # 8080923 in a box marked 405171.Qty: 1 box.

Manufacturer Narrative

H6: investigation summary: two pictures were received by our quality team for evaluation.The photos showed two descriptions of spinal needles, one is the description of the shelf carton that states a material no.405171 (needle spinal s/su 22ga 3in quincke) batch no.9290118 with an expiration date of 30sep2024 and then the needle (individual blister) that is material no.405160 (needle sp s/su 20ga 1-1/4in introducer) lot 8080923 with an expiration date of 31mar2023.Based on the lot numbering material 405171 (22ga 3in quincke) batch no.9290118 is manufactured on oct2019 and the other material 405160 (20ga 1-1/4in introducer) lot 8080923 lot was manufactured a year earlier on apr2018.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.After the investigation, juncos controls regarding reconciliation and label generation was found adequate and did not show a possible root cause for the customer indicated condition.For each lot manufactured and packed at the site, a line clearance is completed and reconciliation is generated.Thus, bd juncos does not retain packed samples after the packaging process was completed.No possible cause has been identified for this complaint related to juncos manufacturing process within this investigation.A possible cause could be that the mix was generated after the bd process.Both lots were received by the same customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: NEEDLE SPINAL S/SU 22GA 3IN QUINCKE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 10706000
• MDR Text Key: 215111499
• Report Number: 2618282-2020-00083
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051717
• UDI-Public: 30382904051717
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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: 405171
• Device Catalogue Number: 405171
• Device Lot Number: 9290118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other