MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC; 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	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz2107 showed no other similar product complaint(s) from this lot number.Device not returned.
Event or Problem Description
It was reported by the customer "hole in catheter near 3cm mark.".
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 by the customer "hole in catheter near 3cm mark." additional information received 09/06/2022: a detailed description of the event: insertion of catheter for long term antibiotics.Stylet removed with mild resistance after confirmation x-ray.Picc catheter flushed and leakage noticed at 3cm mark.¿ what type of catheter securement was utilized? per-q-cath ¿ placement date: 8/4/22 ¿ was there any exposure to blood or chemo? none ¿ was the healthcare provider exposed to the medication?: no ¿ did the patient receive the require dosage? n/a.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed.One 2 fr per-q-cath was returned for evaluation.An initial visual observation showed use residue on the returned sample.The sample was flushed with a 12 ml syringe of water and a leak was found in the catheter tubing at the 2 cm depth marker.A microscopic observation revealed a small diagonal split in the catheter tubing at the leak site, and additional damage was observed on the interior wall of the catheter.The location, extent, and physical characteristics of the damage observed in the returned sample indicate the catheter was likely damaged due to excess friction from the stiffening stylet.This can occur if the stylet is moved within the catheter prior to proper hydration of the stylet and/or due to excessive manipulation of the catheter with the stylet inserted.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer "hole in catheter near 3cm mark." additional information received 09/06/2022: a detailed description of the event: insertion of catheter for long term antibiotics.Stylet removed with mild resistance after confirmation x-ray.Picc catheter flushed and leakage noticed at 3cm mark.What type of catheter securement was utilized? per-q-cath.Placement date: (b)(6) 2022.Was there any exposure to blood or chemo? none.Was the healthcare provider exposed to the medication?: no.Did the patient receive the require dosage? n/a.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC
• 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: 15303632
• Report Number: 3006260740-2022-03356
• Device Sequence Number: 12335660
• Product Code: LJS
• UDI-Device Identifier: 00801741074837
• UDI-Public: (01)00801741074837
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Model Number: N/A
• Device Catalogue Number: 4132105
• Device Lot Number: REFZ2107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 11/14/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/20/2022; 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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 Age: 2 MO
• Patient Sex: Unknown
• Patient Weight: 289 KG