MAUDE Adverse Event Report: CAREFUSION, INC PERITX PERITONEAL CATHETER & STARTER KIT; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Model Number 50-9900C

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2023

Event Type  Injury  

Event Description

It was reported by the customer that the connection to drain and also the cap did not fit properly to the inserted tunneled catheter.Verbatim: after insertion of peritx peritoneal catheter the connection to drain and also the cap did not fit properly to the inserted tunneled catheter.A new kit needed to be opened and reinserted.There were two other catheters with the same lot number 000147154 that was difficult to fit on.(b)(6) 2023: there was no damage noted on the catheter valve initially.The tip of the catheter that locks into the cap or the drainage connecter appeared to be malformed or bent.It would not lock in to either the drainage connector or the cap.The adapter did not appear to be broken.The cap also did not appear broken.Neither of these would lock into the catheter.I'm not sure what is meant by was there a leakage.This occurred during catheter insertion.The catheter had just been inserted when it was noticed.The entire procedure was completed but when i, a technologist and an attending physician tried to connect the catheter to the drainage adapter it would not lock in.We tried multiple times.We also tried bending the locking mechanism into a straighter position (it looked like it possibly was bent inward) (another np noted a similar issue to this recently, being unable to easily lock the catheter to the drainage conector, but was able to kind of shove the lock mechanism into place.This was noted after our procedure but it was found that the catheter had the same lot number).We then had to reinsert a new catheter.This new catheter also had issue locking into the drainage catheter but with some continued aggressive force it locked in.However, this new catheter did lock easily into the cap.The impact to the patient was a much longer sedation time than usual (90 minutes) requiring a second round of sedation when we began to reinsert the tube.We were able to use the same tunnel and insertion site.Per email 02/08/2023 : what product? the catheter was fine; it was not discarded.It seems the piece that is malfunctioning is the drainage connector.It works but you really have to shove it to get it to work.Nothing was discarded.

Manufacturer Narrative

Pr (b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a040609.Patient problem code: f27.

Manufacturer Narrative

(b)(4) follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, it was observed that the valve is damaged.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001473154 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.Manufacturing personnel have been notified of this incident and awareness training was provided.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.H3 other text : see manufacture narration.

Event Description

It was reported by the customer that the connection to drain and also the cap did not fit properly to the inserted tunneled catheter.Verbatim: after insertion of peritx peritoneal catheter the connection to drain and also the cap did not fit properly to the inserted tunneled catheter.A new kit needed to be opened and reinserted.There were two other catheters with the same lot number 000147154 that was difficult to fit on.(b)(6) 2023: there was no damage noted on the catheter valve initially.The tip of the catheter that locks into the cap or the drainage connecter appeared to be malformed or bent.It would not lock in to either the drainage connector or the cap.The adapter did not appear to be broken.The cap also did not appear broken.Neither of these would lock into the catheter.I'm not sure what is meant by was there a leakage.This occurred during catheter insertion.The catheter had just been inserted when it was noticed.The entire procedure was completed but when i, a technologist and an attending physician tried to connect the catheter to the drainage adapter it would not lock in.We tried multiple times.We also tried bending the locking mechanism into a straighter position (it looked like it possibly was bent inward) (another np noted a similar issue to this recently, being unable to easily lock the catheter to the drainage conector, but was able to kind of shove the lock mechanism into place.This was noted after our procedure but it was found that the catheter had the same lot number).We then had to reinsert a new catheter.This new catheter also had issue locking into the drainage catheter but with some continued aggressive force it locked in.However, this new catheter did lock easily into the cap.The impact to the patient was a much longer sedation time than usual (90 minutes) requiring a second round of sedation when we began to reinsert the tube.We were able to use the same tunnel and insertion site.Per email (b)(6) 2023 : what product? the catheter was fine; it was not discarded.It seems the piece that is malfunctioning is the drainage connector.It works but you really have to shove it to get it to work.Nothing was discarded.Yes more than one patient was involved (3).However, only one patient had a catheter replaced due to the issue.There was no impact to the other two patients because the drainage connector was able to be shoved into the catheter.It required more force than previously with other catheters.The catheter was possibly bent in one occurrence (the one in which the catheter was replaced).However, in hindsight and with subsequent procedures it is now theorized that there was no issue with the actual catheter but that it was always the drainage connector.The drainage connector needs to be forcibly inserted into the catheter, whereas it previously easily clicked in.

• Brand Name: PERITX PERITONEAL CATHETER & STARTER KIT
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• 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: 16325968
• MDR Text Key: 309073510
• Report Number: 1625685-2023-00022
• Device Sequence Number: 1
• Product Code: PNG
• UDI-Device Identifier: 10885403501838
• UDI-Public: (01)10885403501838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50-9900C
• Device Catalogue Number: 50-9900C
• Device Lot Number: 0001473154
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other