MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE PLUS IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0057570
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, on (b)(6) 2022, a piece of hair was found inside the sterile package of bard/davol simpulse plus device.There was no report of patient involvement.
Additional Manufacturer Narrative
As reported, a piece of hair was found inside the sterile package of bard/davol simpulse plus device.The subject device has not been received for evaluation.Based on the limited information and not having the sample to evaluate, no conclusion can be made.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 720 units released for distribution in may, 2021.Not returned.
Event or Problem Description
As reported, on (b)(6) 2022, a piece of hair was found inside the sterile package of bard/davol simpulse plus device.There was no report of patient involvement.
Additional Manufacturer Narrative
As reported, a piece of hair was found inside the sterile package of bard/davol simpulse plus device.The subject device has not been received for evaluation.Based on the limited information and not having the sample to evaluate, no conclusion can be made.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 720 units released for distribution in may, 2021.Addendum: h.11 this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation and to correct the patient identifier.Evaluation finds the sample was unused, and the reported foreign material (hair) was found to be present in the product tray.Based on the sample evaluation and investigation performed, the reported event is confirmed.The root cause of the hair presenting within the product packaging is determined to be manufacturing related.Awareness training was provided to appropriate manufacturing personnel.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10, h11 corrected field: a1 (patient identifier) 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.Sample evaluated.

• Brand Name: SIMPULSE PLUS IRRIGATOR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 15190800
• Report Number: 1213643-2022-00578
• Device Sequence Number: 5851378
• Product Code: FQH
• UDI-Device Identifier: 00801741065255
• UDI-Public: (01)00801741065255
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: 0057570
• Device Lot Number: JUFR1378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown