MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER W/ SHERLOCK 3CG TPS STYLET BT 5F DL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Septic Shock (2068)

Event Date 02/16/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs0046 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported " patient who requires change of picc catheter due to infection (septic shock).A new picc catheter is passed in the left basilic vein in a single puncture, but after placement they call us from the icu service informing us that the catheter presents occlusion.The call is answered and a displaced catheter is visualized in the vena cava, it is rearranged, repeated chest and arm x-rays are taken to identify any mechanical occlusion.On saturday the 19th they call us again from the service reporting occlusion for review, the red lumen was occluded as reported from the day of catheter placement.It was decided together with the intensivist to change the catheter.The patient underwent catheter placement again, he was quite immunocompromised and infected.Sample was discarded." this report addresses the infection.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), sterilization records, applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of infection was inconclusive due to the sample condition.Two photographs of a distal section of an explanted powerpicc catheter were returned for evaluation.Residual material, which appeared to be from device use, was present on the catheter.A slight bend in the catheter was visible near the 36 cm depth marker in one of the photos.The second image showed the user manipulating the catheter near the bent region.The catheter was observed to preferentially kink at the previously bent region.The complaint of an infection could not be independently confirmed from evaluation of the returned photos; however, the report of infection has been documented and included in complaint trending.The product was sterilized.Validation and revalidation has demonstrated that the sterilization cycle exceeds the minimum sterility assurance level.Possible contributing factors could include contamination of insertion site, patient sensitivity, and clinical complications.H3 other text: evaluation findings are in section h11.

Event Description

It was reported "patient who requires change of picc catheter due to infection (septic shock).A new picc catheter is passed in the left basilic vein in a single puncture, but after placement they call us from the icu service informing us that the catheter presents occlusion.The call is answered and a displaced catheter is visualized in the vena cava, it is rearranged, repeated chest and arm x-rays are taken to identify any mechanical occlusion.On saturday the 19th they call us again from the service reporting occlusion for review, the red lumen was occluded as reported from the day of catheter placement.It was decided together with the intensivist to change the catheter.The patient underwent catheter placement again, he was quite immunocompromised and infected.Sample was discarded." this report addresses the infection.

• Brand Name: POWERPICC CATHETER W/ SHERLOCK 3CG TPS STYLET BT 5F DL
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13978212
• MDR Text Key: 288400297
• Report Number: 3006260740-2022-01083
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 4275118
• Device Lot Number: REFS0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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