MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL; NEEDLE, SPINAL, SHORT TERM

Model Number 4306C

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Customer stated via email: the vials are shattering and physicians are injuring their hands.Additional information received from customer 8/1/2017: (b)(6) asked me to pass along that two of our physicians have voiced concerns over the current stock of the carefusion adult lumbar puncture tray set.Specifically the glass lidocaine vial that's included.Several vials have shattered when the docs try to use them, resulting in injuries to the physicians.George asked to look into a possible recall for this item.Cat: 4306c with lot no: 0000858285 with lidocaine vendor lot no: 566953a.Additional information received 03-aug-2017: it was two dr and two trays they both got laceration to finger.Both repaired with dermbond and bandaid but they did not want these trays again saying the lidocaine amp shattered instead of snapping off.Additional information received 22-aug-2017: initials, age, gender for each physician: as (b)(6) male.Did you notice an absence of scoring on the lidocaine vials? no.Do you have any samples or photos to return for evaluation? no.

Manufacturer Narrative

(b)(4) follow up emdr submission for device evaluation.A sample was not returned for analysis.A device history record review was completed for lot 0000858285.A non conformance was issued for a missing cap on a vial.This issue is was reconciled and is unrelated to the reported failure.No issues pertaining to the reported failure mode were identified in the device history record report.Malfunctioning drug vials are likely the result of faulty material.A scar (supplier corrective action request) was issued to the supplier for this defect.

• Brand Name: LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6813038
• MDR Text Key: 83421989
• Report Number: 1625685-2017-00310
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4306C
• Device Catalogue Number: 4306C
• Device Lot Number: 0000858285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR