MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 20G X 1" NEEDLELESS Y SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

Patient Problem Infiltration into Tissue (1931)

Event Date 03/16/2022

Event Type  malfunction  

Event Description

It was reported the huber plus needle safety set 20g x 1.0 in with needless y-site bent upon insertion.Patient was accessed on (b)(6) 2022, this issue occurred on (b)(6) 2022 date of occurrence:(b)(6) 2022 was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.Yes ¿ patient had iv fluid infiltrate.

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.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 the huber plus needle safety set 20g x 1.0 in with needless y-site bent upon insertion.Patient was accessed on (b)(6) 2022, this issue occurred on (b)(6) 2022.Date of occurrence: on (b)(6) 2022.Was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.Yes, patient had iv fluid infiltrate.Add info rcvd: was successful port access confirmed via blood aspiration or x-ray? when the port was accessed on (b)(6), there was blood aspiration confirming placement did the iv infiltrate occur on (b)(6) 2022? yes.What was being infused when the infiltration occurred? d5 0.45ns.Did the infiltration require medical treatment? if yes, please describe the treatment and outcome.Warm compress was the bend in the needle discovered during port de-access or at another time during use? discovered with port de-access after discovery of infiltration were there any difficulties encountered during port access? no.Did the safety mechanism function successfully with the bend in the needle? no.Were there any signs of infusion difficulties between on (b)(6)? if yes, will you please describe? no.How was the port needle secured / dressed? yes.Was there any event that inadvertently caused pulling / tugging / bumping the needle or tubing during use? no.Will you confirm that the implanted port continues to function properly with new needle access? yes, the port was re-accessed successfully on (b)(6) for treatment.

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 a bent infusion set needle was confirmed; however, the root cause was not identified.The implicated product was one 20ga x 1¿ huber plus safety infusion set and the returned product was one photograph which depicted a 20ga x 1¿ huber plus safety infusion set.The depicted region of the device included the needle housing and a portion of extension tubing.The safety mechanism was engaged.The needle shaft was bent upward and the needle tip remained outside the safety.The bend occurred near the exit site from the housing.Deformation of the needle shaft was evident in the submitted photograph; however, inspection of the photograph was insufficient to identify the cause of the bend.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include contact between the needle tip and the indwelling port base and lateral pressure placed on the needle during port access.H3 other text: evaluation findings are in section h.11.

• Brand Name: HUBER PLUS 20G X 1" NEEDLELESS Y SITE
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14117870
• MDR Text Key: 289331371
• Report Number: 3006260740-2022-01305
• Device Sequence Number: 1
• Product Code: FPA
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• 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: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• 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
• Patient Age: 20 MO
• Patient Weight: 13 KG