MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after insertion of the picc in a patient, the nurse tested the flow and reflux of the catheter with 0.9% saline solution in a 10 ml syringe, and noticed that there was leakage through a hole in the catheter.Removed the catheter.An attempt was made to insert a new picc, without success.The patient had to be submitted to a central access catheter placement by subclavian puncture by a pediatric surgeon.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reft1133 showed four other similar product complaint(s) from this lot number.
Additional 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.
Event or Problem Description
It was reported after insertion of the picc in a patient, the nurse tested the flow and reflux of the catheter with 0.9% saline solution in a 10 ml syringe, and noticed that there was leakage through a hole in the catheter.Removed the catheter.An attempt was made to insert a new picc, without success.The patient had to be submitted to a central access catheter placement by subclavian puncture by a pediatric surgeon.Additional information received: what was the patient being treated for? parenteral nutrition.
Additional 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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a 2fr s/l per-q-cath catheter.Usage residues were visible on the device, which appeared to have been placed in a patient.The t-lock assembly was attached to the luer adapter.Clear infusate was visible leaking from the catheter shaft near the molded joint.Leakage was visible in the submitted photograph; however, inspection of the photograph was insufficient to identify the cause of the leak.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include sharp instrument contact and damage from contact with the inlaid stylet.
Event or Problem Description
It was reported after insertion of the picc in a patient, the nurse tested the flow and reflux of the catheter with 0.9% saline solution in a 10 ml syringe, and noticed that there was leakage through a hole in the catheter.Removed the catheter.An attempt was made to insert a new picc, without success.The patient had to be submitted to a central access catheter placement by subclavian puncture by a pediatric surgeon.
Additional 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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph and one segment of digital video which depicted a 2fr s/l per-q-cath catheter.The depicted device had an attached t-lock assembly; however, it appeared that the stylet had been removed.The photograph and video both depicted the device during the placement procedure, with the catheter inserted through the introducer.In both the photograph and video, the sample was being flushed through the t-lock assembly luer adapter.A dripping leak was visible near the molded joint.Leakage was evident in both the submitted photograph and video; however, inspection of the provided evidence was insufficient to determine the root cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.The removal of the stylet from the t-lock assembly suggested that traumatic contract between the stylet and the catheter may have caused/contributed to the observed leakage.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported after insertion of the picc in a patient, the nurse tested the flow and reflux of the catheter with 0.9% saline solution in a 10 ml syringe, and noticed that there was leakage through a hole in the catheter.Removed the catheter.An attempt was made to insert a new picc, without success.The patient had to be submitted to a central access catheter placement by subclavian puncture by a pediatric surgeon.Additional information received: ¿ what was the patient being treated for? parenteral nutrition.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET
• Common Device Name: 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15419682
• Report Number: 3006260740-2022-03602
• Device Sequence Number: 20464557
• Product Code: LJS
• UDI-Device Identifier: 00801741074837
• UDI-Public: (01)00801741074837
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 4132105
• Device Lot Number: REFT1133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 10/03/2022; 10/10/2022; 11/14/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/05/2022; 10/14/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown