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

Model Number N/A

Device Problem Activation Problem (4042)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refn1915 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the safety mechanism did not work when the needle was removed.Therefore, physician pulled out the needle without using safety mechanism.There was no reported patient injury.No other information was provided.

Event Description

It was reported that the safety mechanism did not work when the needle was removed.Therefore, physician pulled out the needle without using safety mechanism.There was no reported patient injury.No other information was provided.

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 safety mechanism failure to activate 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.Usage residues were observed throughout the sample.The safety mechanism was not engaged.Attempts to activate the safety mechanism were unsuccessful.The safety was not mobile on the needle shaft.Microscopic inspection of the safety mechanism revealed adhesive residues bonding the safety to the needle shaft.The safety mechanism failure was caused by adhesive which appeared to have been deposited during device assembly.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.H3 other text : evaluation findings are in section h.11.

• Brand Name: HUBER PLUS 22G X 0.75"
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12407585
• MDR Text Key: 269762497
• Report Number: 3006260740-2021-03638
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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: REFN1915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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