MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURGICAL PATTIE, 1/2 X 1/2; SURGICAL SPONGE

Catalog Number 80-1400

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Gtin: not available.Upon completion of the investigation, a follow up report will be filed.

Event Description

Yesterday had drawbacks in skull surgery to insert a cotonoid in the cavity and taking a plaque intensifier can not show white material, thing that is not right because it comes compound with radiopaque material to be showing through rx for patient safety.

Manufacturer Narrative

Upon completion of the investigation it was noted that we received 6 empty packages (open packaged with no product inside).An e-mail explains: i was processing the return the sample, however i detected that there aren´t sample; only empty packaging.I contacted to sales representative and he told me that sample was scrapped in the hospital because of hospital´s politics all contaminated sample are scrapped in the hospital.Without the product it is not possible to perform an evaluation and determine the root cause of this complaint.There have not been any complaints of this type for this product code and lot numbers 512240 (4) and 506914 (2).Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device discarded.

Event Description

Please see below the distributor's answers, about this complaint: are you saying in the complaint that the radiopaque markers did not show up in the x-ray.It was unclear to me what the reported problem was.Also, the complaint lists two items: the first, part number 801400, involves 2 items.The second part number on the complaint, # 801402, involves 4 items.Both of these items are packaged in boxes of 20 packs, each containing 10 patties.My question is: are you saying that the problem is with the packs or the entire box of 200 patties: the look for them in a surgery and did not found the markers, as a result of that they tested the remainder of the stock and where nos able to found the markers, then they call us to replace the all of their stock , which we did.As they see it is a problem with all their stock the entire box, and every part number.Also, please help us with the following questions: were both of these products involved in the same procedure: no they took an image, is not clear if it was an x-ray or a fluoroscopy and did not found the radiopaque markers (one product was used).Did these event occur intra-operatively: yes with in reference number.Did this event cause any delay in surgery over 30 minutes: no.Were there any adverse consequences to the patient: no.What actions were taken as a result of this incident: they took all the remaining stock of patties and tested them under x-ray and where not able to find the radiopaque marker.

• Brand Name: SURGICAL PATTIE, 1/2 X 1/2
• Type of Device: SURGICAL SPONGE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5286410
• MDR Text Key: 33234603
• Report Number: 1226348-2015-10744
• Device Sequence Number: 1
• Product Code: HBN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 80-1400
• Device Lot Number: 506914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2015
• 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): Required Intervention