MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FILL KIT 20G X 10CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported "midline catheter leaking at hub of catheter.Picc nurse noted that when line flushed with normal saline, it leaked back out from the hub." placement date:(b)(6) 2022.Explant date: n/a was there any patient harm reported? no if yes, please describe the harm, how it was treated and the outcome.At what point during device use was the leak discovered (i.E.Insertion, infusion, removal) picc nurse noted that when line flushed with normal saline, it leaked back out from the hub.Was the catheter fracture internal to the patient or external? unknown what was infusion when the leak was discovered? saline any patient symptoms related to fluid leak? unknown was the catheter removed? yes was a new catheter placed? yes what type of catheter securement was utilized? unknown.
Event or Problem Description
It was reported "midline catheter leaking at hub of catheter.Picc nurse noted that when line flushed with normal saline, it leaked back out from the hub." ¿ placement date: 2/28/22.¿ explant date: n/a.¿ was there any patient harm reported? no if yes, please describe the harm, how it was treated and the outcome.¿ at what point during device use was the leak discovered (i.E.Insertion, infusion, removal) picc nurse noted that when line flushed with normal saline, it leaked back out from the hub.Was the catheter fracture internal to the patient or external? unknown ¿ what was infusion when the leak was discovered? saline.¿ any patient symptoms related to fluid leak? unknown.¿ was the catheter removed? yes was a new catheter placed? yes.¿ what type of catheter securement was utilized? unknown.
Additional Manufacturer Narrative
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), sample analysis, applicable fmea documents, and applicable manufacturing records.¿ based on a review of this information, the following was concluded: the complaint of a leak in the catheter was confirmed.The returned sample was a 20g x 10cm powerglide midline catheter.The catheter exhibited evidence of use.The powerglide catheter was kinked just distal to the pink strain relief sleeve.A microscopic examination of the catheter revealed two splits in the circumferential direction on the inside of the kink in the tubing.The splits exposed the inner lumen of the catheter and allowed fluid to leak during a functional test.The wall thickness of the catheter was within specification.The splits in the powerglide catheter appeared to be associated with the kinking of the tubing.The kinking may have been attributable to the securement method, location of the insertion site, and patient movement.No damage associated with the manufacturing process was observed on the returned sample.

• Brand Name: FILL KIT 20G X 10CM WITH BIOPATCH
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: 13905265
• Report Number: 3006260740-2022-00986
• Device Sequence Number: 4075413
• Product Code: FOZ
• UDI-Device Identifier: 00801741140730
• UDI-Public: (01)00801741140730
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• 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): 05/24/2022

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: F320108T
• Device Lot Number: UNKNOWN
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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