MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ARISTA AH FLEXITIP APPLICATOR; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

Catalog Number AM0005

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 03/08/2024

Event Type  malfunction  

Event Description

As reported, the sales rep was at the hospital assisting with cases.In between cases, noticed the or supply closet was low on flexitip xl applicators.When opened the sealed shelf box from the main supply closet, grabbed several applicators and noticed one of the applicators was missing the outer tyvek pouch (product is double pouched).The applicator was within the inner tyvek pouch, just missing the second outer pouch, so it was set aside with a staff member, and it was discarded as a precaution.

Manufacturer Narrative

As reported, arista flexitip xl applicator was missing the outer tyvek pouch.The subject device has been discarded and not available for evaluation.Based on the information available and without having the sample to evaluate, no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note: 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.

• Brand Name: ARISTA AH FLEXITIP APPLICATOR
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 19002840
• MDR Text Key: 339006804
• Report Number: 1213643-2024-00110
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 00801741044076
• UDI-Public: (01)00801741044076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AM0005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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