MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; MIDLINE CATHETER

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 05/31/2022

Event Type  malfunction  

Event Description

It was reported "during midline placement, microez microintroducer with vessel dilator inserted without complications into pts arm, with proper technique.Introducer sheath is meant to break away once midline catheter is in place, one side of the front end of sheath that is held during breakaway portion snapped off of the sheath, leaving the sheath still in place, however without the portion to hold intact.Remainder of the sheath was able to be removed without complication." add info received 06/06/2022: explant date: (b)(6) 2022 was there any patient harm reported? no.

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of regn3992 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "during midline placement, microez microintroducer with vessel dilator inserted without complications into pts arm, with proper technique.Introducer sheath is meant to break away once midline catheter is in place, one side of the front end of sheath that is held during breakaway portion snapped off of the sheath, leaving the sheath still in place, however without the portion to hold intact.Remainder of the sheath was able to be removed without complication." add info received 06/06/2022: explant date: (b)(6) 2022.Was there any patient harm reported? no.

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 lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached sheath is confirmed and was determined to be manufacturing related.One 3.5 fr x 7 cm microintroducer sheath was returned for evaluation.An initial visual observation showed the sheath was returned in three pieces.The proximal end of the detached piece of the sheath was observed to be ragged.A microscopic observation revealed some use residue on the returned sample.The tab on the sheath which is usually within the t-lock handle of the microintroducer was observed to be torn and incomplete.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.H3 other text: evaluation findings are in section h11.

• Brand Name: DOT 3FR SL PROV ML
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14787647
• MDR Text Key: 297220298
• Report Number: 3006260740-2022-02413
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• 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: SP4153108DB
• Device Lot Number: REGN3992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2022
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 36 KG