MAUDE Adverse Event Report: O&M HALYARD, INC. SURGICAL OB PACK IV 5; SURGICAL DRAPES AND PACKS

Model Number	88841
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reporter indicates that while utilizing o&m halyard surgical ob pack, the qbl (quantitative blood loss) drape did not contain the usual measuring component.The patient had a retained placenta and postpartum hemorrhage.Reporter indicates that as a result of the missing drape measuring component, the patient's blood loss was likely underestimated until they had symptomatic anemia.Patient did receive a blood transfusion.
Additional Manufacturer Narrative
The product involved in the event reported is not available for evaluation.All information reasonably known as of (b)(6) 2022 has been included in this medical device report.The information provided by o&m halyard, inc.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 o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
Additional Manufacturer Narrative
The product involved in the event reported is not available for evaluation.The device history record was reviewed for the lot number of the manufactured unit.The lot met all manufacturing process and quality specifications prior to release.No rework or special conditions were reported.No pictures or product samples were provided, therefore the site is unable to further identify the root cause per reported event.All information reasonably known as of 24oct2022 has been included in this medical device report.The information provided by o&m halyard, inc.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 o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.

• Brand Name: SURGICAL OB PACK IV 5
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA S. DE R.L DE C.V; av. hidalgo # 6; colonia parque industrial; nogales, sonora, mexico 84094 ; MX 84094
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 15414199
• Report Number: 3005997949-2022-00002
• Device Sequence Number: 5639988
• Product Code: KKX
• UDI-Device Identifier: 30680651888410
• UDI-Public: 30680651888410
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K083234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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 Model Number: 88841
• Device Catalogue Number: 991088841
• Device Lot Number: AC2210907A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female