MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD DURASAFE¿ COMBINED ANESTHESIA KIT; ANESTHESIA COMBINED SPINAL & EPIDURAL KIT

Catalog Number 400713

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the packaging of the bd durasafe combined anesthesia kit was damaged prior to use.No serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: photo sample returned for investigation.Frequency control is carried out by quality control, reporting zero.Are there samples or photos available? yes photo samples are available.Do the samples require decontamination? n/a frequency control is carried out by quality control, reporting zero defects.Only a photo was received by the customer, where it can be seen that the package where the lodopovidone solution is contained may possibly be damaged and this is what stained the kit.The lot was shoveled on a shift on 20 / sep / 2017, not reporting defective parts.4 pallets remain as final deliverable.It should be noted that both inspections only verify the integrity of the boxes collective, so they are not open during the tras aleo process.Qn's history is verified, finding qn (b)(4), which is not referring to the defect reported by the client.Conclusion: the kit of the batch 7226559 is not manufactured or assembled in bd (b)(4), only the collective box shoveling process (it implies the accommodation for the configuration of pallet and placement), this is done in the transformations area, for its delivery to the cedis, so the package of the kit could not have been damaged in the area of assembly.Root cause: not confirmed.Explain: the kit of lot 7226559 is not manufactured or assembled in bd (b)(4), only the process of shoveling collective cash, so the claim is not confirmed.From the research results, it is concluded that a 2nd mdr evaluation is not necessary.

• Brand Name: BD DURASAFE¿ COMBINED ANESTHESIA KIT
• Type of Device: ANESTHESIA COMBINED SPINAL & EPIDURAL KIT
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7004673
• MDR Text Key: 92484956
• Report Number: 9610847-2017-00150
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K932249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 400713
• Device Lot Number: 7226559
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2017
• 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