MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP; INSTRUMENT, BIOPSY

Model Number DJ4011X

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Material no.: dj4011x, batch no.: 0001364158.It was reported that ins quality control department found a defect at the tip of the needle.Per complaint details received: please, i need your help to contact bd quality control because we have a problem presented in el salvador: 550 units of these needles (dj4011x); the ins quality control department found a defect at the tip of the needle and must return by sub distributor 550 units.07/28/2021 08:22 pm (gmt-3:00) added by (b)(6) ((b)(4)): 1.Presence of uneven edges / burr on the cannula bevel.2.Non-uniform edge in stylet.3.Presence of foreign body.

Event Description

It was reported that ins quality control department found a defect at the tip of the needle.(b)(6) 2021 08:22 pm (gmt-3:00) added by (b)(6) (pid-(b)(6)): non-conformities mentioned in file ((b)(4)): presence of uneven edges/burr on the cannula bevel.Non-uniform edge in stylet.Presence of foreign body.

Manufacturer Narrative

Pr 3182309 follow-up emdr for device evaluation: three photos and 50 physical samples of lot 0001364158 were provided to our quality team for investigation.Through visual inspection, the tip of the needles are observed to have burr and six samples are observed blue foreign matter inside the package , therefore the reported failure could be verified.A review of the internal manufacturing device record and raw material history files for the lot 0001364158 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.A review of machine records verified that all machine parameters were within required limits, no corrective maintenance found, equipment / instruments cannot be associated with failure mode.Through their investigation it was identified that the inconsistency when following the inspection procedure in the packaging area that indicates that the pouch must be shaken to ensure that it is free of particles.Manufacturing personnel have been notified of this incident and additional training was provided.Complaints received for this device and defect will continue to be monitored for future occurrences.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 12249994
• MDR Text Key: 264372645
• Report Number: 9680904-2021-00078
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 10885403087141
• UDI-Public: (01)10885403087141
• Combination Product (y/n): N
• PMA/PMN Number: K171531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

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: Health Professional
• Device Model Number: DJ4011X
• Device Catalogue Number: DJ4011X
• Device Lot Number: 0001364158
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 09/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other