MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SL SAFETY INTRODUCER; 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	08/09/2021
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 redr0515 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when placing the catheter, the clinical head nurse found that the proximal end of the catheter leaked liquid.No other information was provided.
Event or Problem Description
It was reported that when placing the catheter, the clinical head nurse found that the proximal end of the catheter leaked liquid.No other information was provided.
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), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed; however, the exact cause is unknown.One 4 fr single lumen per-q-cath with a stiffening stylet and t-lock inserted and one excalibur introducer device were returned for evaluation.An initial visual observation showed some use residue on the catheter.The catheter was flushed with a 12 ml syringe of water and a spraying leak was observed near the 0 cm depth marker.A microscopic observation revealed a large longitudinal spilt in the catheter at the leak site.The split was observed to be diagonal but straight.The edges of the split were observed to be somewhat rough, and the fracture surfaces were found to be also rough and uneven.One corner of the split was observed to slope slightly from the outer wall of the catheter tubing to the inner wall, suggesting the damage may have originated from an exterior source.The catheter was dissected, and no additional damage was observed on the interior of the catheter tubing.While the exact cause of the damage observed in the returned catheter is unknown, possible causes include instrument damage, stylet damage, and over-pressurization.

• Brand Name: PER-Q-CATH PLUS 4F SL SAFETY INTRODUCER
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12389149
• Report Number: 3006260740-2021-03599
• Device Sequence Number: 14469836
• Product Code: LJS
• UDI-Device Identifier: 00801741074899
• UDI-Public: (01)00801741074899
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 4134115
• Device Lot Number: REDR0515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• 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