MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD MIDLINE; MIDLINE CATHETER

Model Number N/A

Device Problems Material Deformation (2976); Difficult or Delayed Separation (4044)

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

Event Date 10/02/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported by the customer "the dilator would not come apart and it seemed that the catheter portion of the dilator was adhered incorrectly to the stabilizer.The scalpel was used to get it apart.".

Event Description

It was reported by the customer "the dilator would not come apart and it seemed that the catheter portion of the dilator was adhered incorrectly to the stabilizer.The scalpel was used to get it apart.".

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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an improper peel is confirmed and the cause appears to be manufacturing related.One 4.5 fr microez microintroducer was returned for evaluation.The dilator was not returned.The orange peel tabs and sheath was returned split.The orange tab split surface revealed one tab to contain an uneven amount of the material.The extra material formed a complete ring which likely contributed to a difficult removal from the catheter.Based on the information provided, the characteristics of the material properties likely contributed to the uneven tab peel; therefore, the complaint is confirmed.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.H3 other text : evaluation findings are in section h.11.

• Brand Name: BARD MIDLINE
• Type of Device: MIDLINE CATHETER
• 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: 15633834
• MDR Text Key: 307010947
• Report Number: 3006260740-2022-04067
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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