MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refq2498 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a contamination of black foreign material was found in the package.There was no reported patient involvement.No other information was provided.

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 black foreign material within the infusion set was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 22ga x 0.75¿ huber plus safety infusion set.The sample was received in its original sealed package.The package seal was complete and unremarkable.Two pieces of black material were observed within the sealed package.Microscopic inspection of the sample confirmed the presence of material within the sealed package.The objects appeared consistent with fragments of polymer type material.The sealed state of the packaging indicated that the black material was deposited within the packaging during device assembly/packaging.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.

Event Description

It was reported that a contamination of black foreign material was found in the package.There was no reported patient involvement.No other information was provided.

• Brand Name: HUBER PLUS 22G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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 ; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780 ; 8999213000
• MDR Report Key: 12656818
• MDR Text Key: 277203500
• Report Number: 3006260740-2021-04420
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K993848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• 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: 8012234
• Device Lot Number: REFQ2498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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