MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH 15 CM PRE-CURVE KIT; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Crack (1135); Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

It was reported, "when the physician was going to perform the implant of the catheter, and while trying to introduce the guide introducer needle and suction to be sure it was placed in blood vessel, there was no vacuum and only air was being suctioned, therefore it was not possible to be sure the device was in its proper place.It was decided to remove it and use a new device.".

Manufacturer Narrative

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 air aspiration during introducer needle insertion was inconclusive due to the condition of the returned sample.The product returned for evaluation was one photograph depicting an 18ga introducer needle.The depicted device was located in its original opened packaging tray.The plastic needle cover was in place over the needle shaft.No obvious use residues were observed.No details about the implicated introducer needle were discernible in the submitted photograph.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of reeu2429 showed no other similar product complaint(s) from this lot number.

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), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leaking introducer needle was confirmed but the exact cause remains unknown.The product returned for evaluation was one 18 ga introducer needle.The returned product sample was evaluated and the luer connector was observed to be cracked.The fracture features were consistent with outward radiating forces originating within the luer hub orifice, and the characteristics observed which supported this type of failure included: multiple cracks were observed which were longitudinally aligned.Multiple superficial cracks were also seen surrounding the primary damage and were also longitudinally aligned.Functional testing of infusion revealed a leak(s) emanating from the crack(s).Functional testing of aspiration showed that air was drawn into the syringe with test water.It was determined that the forceful insertion of a connecting device may have contributed to the observed damage; however, attempts to replicate this type of failure were unsuccessful which suggested that additional unidentified contributing factors may have also been involved.Consequently, the event was classified as cause unknown.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported, "when the physician was going to perform the implant of the catheter, and while trying to introduce the guide introducer needle and suction to be sure it was placed in blood vessel, there was no vacuum and only air was being suctioned, therefore it was not possible to be sure the device was in its proper place.It was decided to remove it and use a new device.".

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 air aspiration during introducer needle insertion was inconclusive due to the condition of the returned sample.The product returned for evaluation was one photograph depicting an 18ga introducer needle.The depicted device was located in its original opened packaging tray.The plastic needle cover was in place over the needle shaft.No obvious use residues were observed.No details about the implicated introducer needle were discernible in the submitted photograph.Consequently this complaint is inconclusive at this time.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported, "when the physician was going to perform the implant of the catheter, and while trying to introduce the guide introducer needle and suction to be sure it was placed in blood vessel, there was no vacuum and only air was being suctioned, therefore it was not possible to be sure the device was in its proper place.It was decided to remove it and use a new device.".

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 initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.

Event Description

It was reported, "when the physician was going to perform the implant of the catheter, and while trying to introduce the guide introducer needle and suction to be sure it was placed in blood vessel, there was no vacuum and only air was being suctioned, therefore it was not possible to be sure the device was in its proper place.It was decided to remove it and use a new device.".

• Brand Name: NIAGARA SLIM-CATH 15 CM PRE-CURVE KIT
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12869290
• MDR Text Key: 281207360
• Report Number: 3006260740-2021-05014
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K010778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/03/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 5554150
• Device Lot Number: REEU2429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 11/29/2021; 12/29/2021; 02/02/2022
• Supplement Dates FDA Received: 12/02/2021; 12/30/2021; 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other