MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS TRAY 8FR X 16CM; THORACENTESIS TRAY

Model Number	PIG1280T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that the shield is not retracting.Verbatim: blunt tip needle shield is supposed to retract and expose the needle, but the shield is not retracting.Occurred on (b)(6) at 12 o'clock and another (b)(6) at 1 o'clock.(b)(6) 2022: there were two separate incidents.The first one occurred on (b)(6).Here are the details from that incident.Patient needing a lvp.Resident md attempted lvp but after x2 attempts, was unable to access pocket despite providing large amount of pressure to needle and patient having roughly 13l of fluid in his abdomen.Following day upon discussion w/ another md, she noted same problem performing a paracentesis and noted that the blunt edge of the needle does not retract to a sharp needle when pressure is applied which is likely why reporters resident was unable to access the peritoneum.Lot # of para kit 0001434054.The second incident occurred on (b)(6).Here are the details from that incident.39 yo man with etoh/nash cirrhosis admitted with recurrent culture negative sbp.Tried to do repeat diagnostic paracentesis today and multiple kits contained faulty 8 fr safe-t-centesis catheter drainage devices.Patient safety issue for multiple reasons: 1.Providers are providing too much pressure to try to advance into the peritoneal space when it will not because it has a malfunctioning blunt tip.This could lead to injury of patients.2.Providers are not able to advance into peritoneal space so paracenteses aren't happening when they're needed.These kits may need to be pulled and replaced.The caldwell needles have had no issue and could be used instead.Reporters team went through multiple kits and they were defective.Description: there's a blunt tip that's a safety mechanism.It should retract and expose the needle if any pressure is applied.That allows you to advance your needle into the patient and then once it's in the abdominal cavity and there's no longer pressure on it, the blunt tip pops back out so you can drain fluid without an exposed needle (that could poke bowel or something else).That blunt tip in these kits does not retract with pressure, so the needle is never exposed and people are basically trying to jam a blunt tip pencil through a patient's abdominal wall.(b)(6) 2022: repeat attempts were needed for both which does carry a risk with it.One patient was delayed until the next day and subsequently decompensated though for unrelated reasons.Ons.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
It was reported by the customer that the shield is not retracting.Verbatim: blunt tip needle shield is supposed to retract and expose the needle, but the shield is not retracting.Occurred on 6/20 at 12 o'clock and another 6/18 at 1 o'clock 24jun2022: there were two separate incidents.The first one occurred on june 18th.Here are the details from that incident.Patient needing a lvp.Resident md attempted lvp but after x2 attempts, was unable to access pocket despite providing large amount of pressure to needle and patient having roughly 13l of fluid in his abdomen.Following day upon discussion w/ another md, she noted same problem performing a paracentesis and noted that the blunt edge of the needle does not retract to a sharp needle when pressure is applied which is likely why reporters resident was unable to access the peritoneum.Lot # of para kit 0001434054.The second incident occurred on june 20th.Here are the details from that incident.39 yo man with etoh/nash cirrhosis admitted with recurrent culture negative sbp.Tried to do repeat diagnostic paracentesis today and multiple kits contained faulty 8 fr safe-t-centesis catheter drainage devices.Patient safety issue for multiple reasons: 1.Providers are providing too much pressure to try to advance into the peritoneal space when it will not because it has a malfunctioning blunt tip.This could lead to injury of patients.2.Providers are not able to advance into peritoneal space so paracenteses aren't happening when they're needed.These kits may need to be pulled and replaced.The caldwell needles have had no issue and could be used instead.Reporters team went through multiple kits and they were defective.Description: there's a blunt tip that's a safety mechanism.It should retract and expose the needle if any pressure is applied.That allows you to advance your needle into the patient and then once it's in the abdominal cavity and there's no longer pressure on it, the blunt tip pops back out so you can drain fluid without an exposed needle (that could poke bowel or something else).That blunt tip in these kits does not retract with pressure, so the needle is never exposed and people are basically trying to jam a blunt tip pencil through a patient's abdominal wall.29jun2022: repeat attempts were needed for both which does carry a risk with it.One patient was delayed until the next day and subsequently decompensated though for unrelated reasons.
Additional Manufacturer Narrative
Pr 5453594 follow-up emdr for device evaluation: one photo and one physical sample of an 8fr veress safety needle was provided to our quality team for investigation.Functional testing was performed on the product, the safety introducer needle assembly gently loaded into the proximal end of the catheter drainage assembly.Ensure a complete engagement of the threaded valve hub and the safety introducer needle assembly to unlock the blunt obturator the blunt end retracted; therefore, the reported failure could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001434054 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.Based on the available information we are not able to identify a root cause at this time.Scar was issued to the supplier.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: SAFE-T-CENTESIS TRAY 8FR X 16CM
• Common Device Name: THORACENTESIS TRAY
• 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: 15007266
• Report Number: 1625685-2022-00076
• Device Sequence Number: 6856216
• Product Code: PXI
• UDI-Device Identifier: 10885403108402
• UDI-Public: (01)10885403108402
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PIG1280T
• Device Catalogue Number: PIG1280T
• Device Lot Number: 0001434054
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown