MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SL PICC W/SAFETY EXCALIBUR INTRO PG; 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	07/08/2021
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 redw2590 showed three other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that this patient was admitted to hospital due to cerebral infarction and had a pqc catheter placed due to the need for short- and mid-term iv infusion of drugs.During ward rounds on (b)(6) 2021, the nurse found that the catheter was ruptured at the 0 scale.
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, applicable previous investigation(s), applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a ruptured catheter was confirmed.One 4 fr catheter and injection cap was returned for evaluation.The catheter had been cut at the 30 cm mark and what appeared to be blood residue could be seen inside and on the catheter.The catheter was broken into two pieces proximal to the 0 cm mark, where the catheter body and the molded wings join.The break appears to be jagged and a microscopic evaluation showed that the break site was granular and uneven.The break was level along the clear portion of the catheter but becomes uneven along the white stripe.Since the returned sample was ruptured, the compliant is confirmed but the exact cause in unknown.Based on the description of the reported event and evaluation of the returned sample, possible contributing factors could include material fatigue and tensile (pulling) damage.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that this patient was admitted to hospital due to cerebral infarction and had a pqc catheter placed due to the need for short- and mid-term iv infusion of drugs.During ward rounds on (b)(6) 2021, the nurse found that the catheter was ruptured at the 0 scale.

• Brand Name: PER-Q-CATH PLUS 4F SL PICC W/SAFETY EXCALIBUR INTRO PG
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12255266
• Report Number: 3006260740-2021-03065
• Device Sequence Number: 4950635
• 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): 11/08/2021

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: REDW2590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2019
• 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