MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE; TRAY, SURGICAL, NEEDLE

Model Number 405671

Device Problems Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no: 405671, batch no: 0001392054.It was reported staff identified floating in the syringe are 2 gray matter objects verbatim: per customer's response (b)(6) 2021.Date of event was (b)(6) and they will be sending product to you for review.Thanks! the head of our anesthesia department brought me a syringe that was drawn up from the bd spinal anesthesia tray, product code 405671, lot number 0001392054, serial number (b)(4), expiration date 2021-12-31.He states the staff drew up the marcaine vial through the filtered needle.Staff identified floating in the syringe are 2 gray matter objects.The syringe was immediate quarantined and not administered to any patient.We also pulled all kits with this lot number from our stock.We do have the syringe with the solution present and also the ampule of marcaine.Please let me know how you would like to receive this and what address we can send to.We would also like to arrange for return of the other kits with the lot number and arrange a credit for all kits, including the one opened and used.Thank you for your immediate attention to this matter.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-02-23.H6: investigation summary one glass syringe sample was provided to our quality team for investigation.Through visual inspection, it was observed that the gray particles floating inside syringe, therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the lot 0001392054 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections throughout manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Investigation was not able to determine at what point the material of concern (foreign matter) was introduced (syringe supplier, manufacture of the tray 405671, during distribution or at the end user).Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see h10.

Event Description

Material no: 405671 batch no: 0001392054.It was reported staff identified floating in the syringe are 2 gray matter objects verbatim: per customer's response (b)(6) 2021.Date of event was (b)(6) and they will be sending product to you for review.Thanks! the head of our anesthesia department brought me a syringe that was drawn up from the bd spinal anesthesia tray, product code 405671.Lot number 0001392054.Serial number (b)(6).Expiration date 2021-12-31.He states the staff drew up the marcaine vial through the filtered needle.Staff identified floating in the syringe are 2 gray matter objects.The syringe was immediate quarantined and not administered to any patient.We also pulled all kits with this lot number from our stock.We do have the syringe with the solution present and also the ampule of marcaine.Please let me know how you would like to receive this and what address we can send to.We would also like to arrange for return of the other kits with the lot number and arrange a credit for all kits, including the one opened and used.Thank you for your immediate attention to this matter.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
• Type of Device: TRAY, SURGICAL, NEEDLE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11294461
• MDR Text Key: 230773565
• Report Number: 1625685-2021-00015
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: 0001392054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other