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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE PLUS IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE PLUS IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0057570
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2022
Event Type  malfunction  
Event 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.
 
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 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.
 
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.
 
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Brand Name
SIMPULSE PLUS IRRIGATOR
Type of Device
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 Key15190800
MDR Text Key297538697
Report Number1213643-2022-00578
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00801741065255
UDI-Public(01)00801741065255
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K942886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0057570
Device Lot NumberJUFR1378
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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